Hydraulic delivery systems for prosthetic heart valve devices and associated methods

ABSTRACT

Systems, apparatuses, and methods for treating native heart valves are disclosed herein. A system for delivering a prosthetic device into a heart of a patient includes an elongated catheter body and a delivery capsule. The delivery capsule can be hydraulically driven to deploy at least a portion of a prosthetic heart valve device. The delivery capsule can release the prosthetic heart valve device at a desired treatment site in a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Division of and claims priority to U.S.patent application Ser. No. 13/781,504, filed Feb. 28, 2013, whichclaims priority under 35 U.S.C. § 119(e) to U.S. Provisional PatentApplication No. 61/605,699, filed Mar. 1, 2012, and entitled “SYSTEM FORMITRAL VALVE REPLACEMENT,” and U.S. Provisional Patent Application No.61/760,399, filed Feb. 4, 2013, and entitled “HYDRAULIC DELIVERY SYSTEMSFOR PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED METHODS,” thedisclosures of which are incorporated herein by reference in theirentireties.

TECHNICAL FIELD

The present technology relates generally to hydraulic delivery systemsand methods for using the same. In particular, several embodiments aredirected to hydraulic delivery systems for delivering prosthetic heartvalve devices.

BACKGROUND

During a normal cycle of heart contraction (systole), when the leftventricle contracts, the mitral valve acts as a check valve to preventflow of oxygenated blood back into the left atrium. Oxygenated blood canbe pumped into the aorta through the aortic valve. Regurgitation of themitral valve can significantly decrease the pumping efficiency of theheart, placing the patient at risk of sever, progressive heart failure.Mitral valve regurgitation can be characterized by retrograde flow fromthe left ventricle of a heart through an incompetent mitral valve intothe left atrium. Mitral valve regurgitation can result from a number ofmechanical defects. For example, leaflets, chordac tendineae coupled tothe leaflets, or the papillary muscles of the mitral valve may bedamaged or otherwise dysfunctional. In at least some instances, themitral valve's annulus supporting the leaflets may be damaged, dilated,or weakened, thereby limiting the ability of the mitral valve to closeadequately against the high pressures of the left ventricle.

Mitral valve replacement is often performed to treat mitral valves.Unfortunately, mitral valve replacement poses unique anatomicalobstacles, rendering mitral valve replacement procedures risky and morechallenging than other types of valve replacements, such as aortic valvereplacement. This is because the mitral valve annulus often has anon-circular D shape or kidney like shape, with a non-planar geometry.It may be difficult to properly position a prosthetic mitral valvewithin the native mitral valve. If the prosthetic mitral valve is at animproper orientation, blood may flow through gaps between the prostheticmitral valve and the leaflets and/or annulus of the native mitral valve.Percutaneous catheters can be used to delivery prosthetic valves.Unfortunately, self-expanding prosthetic mitral valves can deploy in anuncontrolled manner due to axial jumping or self-ejection. Thecontrolled deployment of prosthetic mitral valves can result in improperpositioning of the prosthetic mitral valve resulting in leakage,migration of the prosthetic mitral valve, and other unwanted problems.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components may be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent.

FIGS. 1 and 1A are schematic illustrations of a mammalian heart havingnative valve structures suitable for replacement with prosthetic devicesin accordance with embodiments of the present technology.

FIG. 1A-1 is a schematic cross-sectional side view of a native mitralvalve of a mammalian heart.

FIG. 1B is a schematic illustration of the left ventricle of a hearthaving prolapsed leaflets in the native mitral valve, and which issuitable for treatment with systems in accordance with embodiments ofthe present technology.

FIG. 1C is a schematic illustration of a heart in a patient sufferingfrom cardiomyopathy, and which is suitable for treatment with systems inaccordance with embodiments of the present technology.

FIG. 1C-1 is a schematic illustration of a native mitral valve of aheart showing normal closure of native mitral valve leaflets.

FIG. 1C-2 is a schematic illustration of a native mitral valve of aheart showing abnormal closure of native mitral valve leaflets in adilated heart, and which is suitable for treatment with systems inaccordance with embodiments of the present technology.

FIG. 1D illustrates mitral valve regurgitation in the left ventricle ofa heart having impaired papillary muscles, and which is suitable fortreatment with systems in accordance with embodiments of the presenttechnology.

FIG. 1E is a schematic illustration of a native mitral valve of a heartshowing dimensions of the annulus, and which is suitable for treatmentwith systems in accordance with embodiments of the present technology.

FIG. 1F is a schematic cross-sectional illustration of the heart showingan antegrade approach to the native mitral valve from the venousvasculature in accordance with various embodiments of the presenttechnology.

FIG. 1G is a schematic cross-sectional illustration of the heart showingaccess through the interatrial septum (IAS) maintained by the placementof a guide catheter over a guidewire in accordance with variousembodiments of the present technology.

FIGS. 1H and 1I are schematic cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature in accordance with variousembodiments of the present technology.

FIG. 1J is a schematic cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present invention.

FIG. 2A is a schematic cross-sectional illustration of the heart and adelivery capsule positioned in a native mitral valve of the heart inaccordance with various embodiments of the present technology.

FIG. 2B shows the delivery capsule of FIG. 2A in a deploymentconfiguration and a deployed prosthetic device in accordance withvarious embodiments of the present technology.

FIG. 3 is an isometric view of a system for delivering prostheticdevices configured in accordance with various embodiments of the presenttechnology.

FIG. 4 is an isometric view of a distal portion of the system of FIG. 3.

FIG. 5 is an exploded isometric view of the distal portion of FIG. 3 inaccordance with various embodiments of the present technology.

FIG. 6 is a cross-sectional view of the distal portion taken along line6-6 of FIG. 4.

FIG. 7 is a cross-sectional view of a control unit of the system of FIG.3.

FIG. 8 is a detailed cross-sectional view of internal components of thecontrol unit of FIG. 7.

FIG. 9 is a cross-sectional view of the control unit taken along line9-9 of FIG. 7.

FIG. 10 is a cross-sectional view of a rotational control assembly inaccordance with various embodiments of the present technology.

FIGS. 11-14 are a series of views of a method of deploying a prostheticdevice from a delivery capsule in accordance with various embodiments ofthe present technology.

FIGS. 15-17 are a series of views of a method of deploying a prostheticdevice from a delivery capsule in accordance with various embodiments ofthe present technology.

FIG. 18 is an isometric view of a catheter for delivering a prostheticdevice in accordance with various embodiments of the present technology.

FIG. 19 is a side view of a control unit of the catheter of FIG. 18 inaccordance with various embodiments of the present technology.

FIG. 20 is a cross-sectional view of the control unit taken along line20-20 of FIG. 19.

FIG. 21 is an exploded isometric view of a distal portion of thecatheter of FIG. 18.

FIG. 22 is a cross-sectional view of the distal portion of the catheterof FIG. 18.

FIGS. 23-25 are a series of views of a method of deploying a prostheticdevice from a delivery capsule of FIG. 22 in accordance with variousembodiments of the present technology.

FIGS. 26-29 are a series of views of a method of deploying a prostheticdevice within a native mitral valve in accordance with variousembodiments of the present technology.

FIG. 30 is an isometric view of a distal portion of a catheter inaccordance with various embodiments of the present technology.

FIGS. 31 and 32 are isometric cutaway views of the distal portion ofFIG. 30.

FIGS. 33-35 are a series of views of a method of deploying a prostheticdevice from the catheter of FIG. 30.

FIG. 36 is a cross-sectional view of a distal portion of a catheter inaccordance with various embodiments of the present technology.

FIG. 37 is a cross-sectional view of the distal portion of FIG. 36holding a prosthetic device in a partially expanded configuration.

FIG. 38 is an isometric view of a positioner in accordance with variousembodiments of the present technology.

FIG. 39 is an exploded cross-sectional view of the distal portion ofFIG. 36 in accordance with various embodiments of the presenttechnology.

FIG. 40 is an isometric view of a catheter for delivering a prostheticdevice in accordance with various embodiments of the present technology.

FIG. 41 is an isometric cutaway view of a control unit of the catheterof FIG. 40 in accordance with various embodiments of the presenttechnology.

FIG. 42 is a side view of a drive mechanism of the control unit of FIG.41.

FIG. 43 is a detailed side view of a portion of the control unit of FIG.41.

FIG. 44 is a schematic cross-sectional illustration of the heart and acatheter for transapically delivering a prosthetic device within anative mitral valve in accordance with various embodiments of thepresent technology.

FIG. 45 shows a delivery capsule of the catheter of FIG. 44 aligned withthe mitral valve.

FIG. 46 is an isometric view of a distal portion of a catheter inaccordance with various embodiments of the present technology.

FIG. 47 is a top view of a positioning assembly in accordance withvarious embodiments of the present technology.

FIG. 48 is a cross-sectional view of the positioning assembly takenalong line 48-48 of FIG. 47.

FIGS. 49-53 are a series of views of a method of aligning a deliverycapsule with a native mitral valve in accordance with variousembodiments of the present technology.

FIGS. 54-56 are a series of views of a method of aligning a deliverycapsule with a native mitral valve in accordance with another embodimentof the present technology.

FIG. 57 is a schematic cross-sectional illustration of the heart and adistal portion of a catheter positioned in a mitral valve in accordancewith another embodiment of the present technology.

FIG. 58 is a cross-sectional side view of the distal portion of FIG. 57.

FIG. 59 is an isometric view of a system for delivering a prostheticdevice in accordance with various embodiments of the present technology.

FIG. 60 is a cross-sectional view of a distal portion of the systemtaken along line 60-60 of FIG. 59.

FIGS. 61-65 are a series of views of a method of positioning the distalportion of FIG. 60 in accordance with various embodiments of the presenttechnology.

FIG. 66 is a cross-sectional side view of a distal portion of a catheterin accordance with various embodiments of the technology.

FIG. 67 is a top view of a distal portion of a catheter positioned in anative mitral valve in accordance with various embodiments of thetechnology.

FIG. 68 is a cross-sectional side view of the distal portion of FIG. 67taken along line 68-68.

FIG. 69 shows a distal portion of a catheter in a guide catheter inaccordance with various embodiments of the technology.

FIG. 70 shows a delivery capsule that has been delivered out of theguide catheter of FIG. 69.

FIG. 71 is a schematic cross-sectional illustration of the heart and adistal portion of a catheter positioned in a mitral valve in accordancewith another embodiment of the technology.

FIG. 72 shows deployed positioners of the distal portion of FIG. 71contacting the heart.

FIGS. 73 and 74 are a series of views of a method of positioning adistal portion a catheter using a transapical approach in accordancewith various embodiments of the technology.

FIG. 75 is a top view of a valve locator engaging a native mitral valvein accordance with various embodiments of the technology.

FIG. 76 is a schematic cross-sectional illustration of the heart and thevalve locator taken along line 76-76 of FIG. 75.

FIG. 77 is a top view of a kit for delivering devices into a patient inaccordance with various embodiments of the technology.

DETAILED DESCRIPTION

The present technology is generally directed to treatment of heartvalves and another anatomical structures. Specific details of numerousembodiments of the technology are described below with reference toFIGS. 1-77. Although many of the embodiments are described below withrespect to catheter systems, prosthetic devices, and methods fortreating a native heart valve using prosthetic devices, otherapplications and other embodiments in addition to those described hereinare within the scope of the technology. A person of ordinary skill inthe art will understand that the technology can have other embodimentswith additional elements, or the technology can have other embodimentswithout several of the features shown and described below with referenceto FIGS. 1-77.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a system, catheter, and/orassociated delivery equipment with reference to an operator and/or alocation in the patient. For example, in referring to a cathetersuitable to deliver and position various prosthetic devices describedherein, “proximal” can refer to a position closer to the operator of thecatheter or an incision into vasculature, and “distal” can refer to aposition that is more distant from the operator of the catheter orfurther from the incision along the vasculature (e.g., a position at anend of the catheter). For ease of reference, throughout this disclosureidentical reference numbers and/or letters are used to identify similaror analogous components or features, but the use of the same referencenumber does not imply that the parts should be construed to beidentical. Indeed, in many examples described herein, the identicallynumbered parts are distinct in structure and/or function. The headingprovides herein are for convenience only.

Overview

The present technology is directed generally to systems, apparatuses,and methods to treat one or more sites in a subject's body. For example,at least some embodiments of the present technology can be used to treatheart valves (e.g., mitral valves, aortic valves, tricuspid valves,and/or pulmonic valves). The treatment can include, without limitation,valve replacement, valve repair, valve alternation, or other proceduresthat affect functioning of the valve. The apparatuses and methods canenable a percutaneous approach using a catheter deliveredintravascularly through a vein or an artery into the heart. Thecatheters and methods also enable other less-invasive approachesincluding, without limitation, trans-apical approaches, trans-atrialapproaches, and direct aortic delivery. In more invasive approaches, thecatheters and methods enable invasive approaches, including openprocedures.

In some embodiments, a catheter includes a delivery device configured tocontain a prosthetic device (e.g., a prosthetic heart valve device, areplacement heart valve, etc.). The delivery device can be a capsulereconfigured to deploy the prosthetic device. In some embodiments, thedelivery device can be moved from a containment configuration forholding the prosthetic device to a deployment configuration to deploythe prosthetic device. For example, at least a portion of the capsulecan be actuated (e.g., hydraulically actuated, mechanically actuated,etc.) to unsheathe or otherwise release at least a portion of theprosthetic device.

The capsule can controllably deploy the prosthetic device to minimize,limit, or substantially eliminate uncontrolled movement of theprosthetic device. In some embodiments, the capsule can limit, minimize,or substantially eliminate axial jumping, self-ejection, and/or movementof the prosthetic device that may cause misalignment with the nativevalve. In some embodiments, the capsule (e.g., a prosthetic mitralvalve) holds the prosthetic device stationary relative to, for example,the native valve, chambers of heart on opposing sides of the nativevalve, or the like.

The prosthetic device in a delivery configuration can have an outerdiameter of about 8 mm to about 12 mm for trans-apical approaches. Theprosthetic device can also have a low profile suitable for deliverythrough small-diameter guide catheters positioned in the heart via thetrans-septal, retrograde, or other approaches described herein. Forexample, the prosthetic device in the delivery configuration can have anouter diameter equal to or less than about 10 mm for trans-septalapproaches. In some embodiments, the outer diameter of the trans-septalprosthetic device is about 8 mm to about 10 mm. The prosthetic device inthe delivery configuration can have an outer diameter equal to about 8mm to about 10 mm for retrograde approaches. Other dimensions are alsopossible.

The prosthetic devices can be configured to expand to a deployedconfiguration. “Deployed configuration,” as used herein with respect toa prosthetic device, generally refers to the prosthetic device onceexpanded at a delivery site (e.g., a native valve site) and subject tothe constraining and distorting forces exerted by the native anatomy. Asused herein, “expanded configuration” generally refers to theconfiguration of a device when allowed to freely expand to anunrestrained size without the presence of constraining or distortingforces.

As used herein, the term “housing” generally refers to a structurecapable of covering a prosthetic device. In some embodiments, thehousing can include multiple sheaths (e.g., a pair of sheathes). Inother embodiments, the housing can include a single sheath and a cover.The cover can be used to close and open an open end of the sheath. Inyet further embodiments, the housing can be a clam shell assembly thatincludes, without limitation, a pair of clam shells that can be movedapart to deploy the prosthetic device. The configuration and componentsof the housing can be selected based on, for example, the delivery path,treatment site, and/or configuration of the prosthetic device. In stillfurther embodiments, the housing is part of a delivery capsule.

In some embodiments, a catheter for delivering a prosthetic device intoa heart of a patient comprises a delivery capsule movable betweendifferent configurations (e.g., a containment configuration for holdingthe prosthetic device, a deployment configuration for deploying theprosthetic device, etc.) and a positioner (e.g., a percutaneous elongatepositioner). The positioner is movable from a delivery state to atissue-contacting state. The positioner in the tissue-contacting stateis configured to contact tissue of the heart to position the prostheticdevice contained in the delivery capsule relative to a native valvewhile the delivery capsule is reconfigured to deploy the prostheticdevice within the native valve.

In some embodiments, a system may include a catheter with a controldevice. The control device can be configured to deploy the prostheticdevice by hydraulically releasing at least a portion of the prostheticdevice. For example, in some embodiments a portion of the prostheticdevice can be unsheathed mechanically and another portion of theprosthetic device can be unsheathed hydraulically. In other embodiments,however, the entire prosthetic device may be unsheathed hydraulically.The delivery capsule can be biased to counteract forces produced by theprosthetic device. In some embodiments, for example, a biasing force cancounteract the forces produced by a self-expanding prosthetic device.

In some embodiments, for example, the control unit can be used toposition the prosthetic device carried by the catheter to the treatmentsite. The control unit can include, without limitation, a screw-drivemechanism to controllable move at least a portion of housing tounsheathe a first portion of the prosthetic device. Another portion ofthe prosthetic device can be unsheathed before, during, and/or afterunsheathing of the first portion of the prosthetic device. Additionallyor alternatively, the control unit can include a slider mechanism usedto axially move at least a portion of the housing to unsheathe theprosthetic device. In still further embodiments, the control unit mayinclude other features and/or a different configuration.

In further embodiments, a system for implantation of a prosthetic heartvalve device comprises an elongated catheter body and a delivery capsulecoupled to the elongated catheter body. The delivery capsule isconfigured to contain a prosthetic heart valve device. The deliverycapsule is configured to by hydraulically driven to deploy theprosthetic device (e.g., a prosthetic heart valve device). In someembodiments, the delivery capsule can include a housing and a hydraulicmechanism (e.g., a piston device) that contacts the housing to inhibitmovement of the delivery capsule from a containment configuration to adeployment configuration. The hydraulic mechanism can include one ormore piston devices that contact the housing. Additionally oralternatively, the delivery capsule can include a biasing device thaturges at least a portion of the delivery capsule towards a containmentconfiguration when the delivery capsule moves from a containmentconfiguration towards a deployment configuration.

In some embodiments, a system for delivering a prosthetic deviceincludes an elongated catheter body, a housing, a plunger or piston, anda prosthetic device. The housing can be coupled to the elongatedcatheter body and can include a distal nose cone and a proximal capsule.In some embodiments, the housing can include a split sheath. Theprosthetic device and the plunger can be positioned in the housing toallow hydraulic actuation of the housing. The prosthetic device can bedeployed in a controlled manner to minimize or limit jumping of theprosthetic device.

Cardiac Physiology

FIGS. 1 and 1 a show a heart H that comprises a right atrium RA and aright ventricle RV that receive blood from the body and pump the bloodfrom the body to the lungs. The left atrium receives oxygenated bloodfrom the lungs via the pulmonary veins PV and pumps this oxygenatedblood through the mitral MV into the left ventricle LV. The leftventricle LV pumps the blood through the aortic valve AV into the aortafrom which it flows throughout the body.

The left ventricle LV of a normal heart H in systole is illustrated inFIG. 1A. In systole, the left ventricle LV contracts and blood flowsoutwardly through the aortic valve AV in the direction of the arrows.Back flow of blood or “regurgitation” through the mitral valve MV isprevented since the mitral valve is configured as a “check valve” whichprevents back flow when pressure in the left ventricle is higher thanthat in the left atrium LA. The mitral valve MV comprises a pair ofleaflets having free edges FR which meet evenly, or “coapt” to close, asillustrated in FIG. 1A. The opposite ends of the leaflets LF areattached to the surrounding heart structure via an annular region oftissue referred to as the annulus AN. The free edges FE of the leafletsLF are secured to the lower portions of the left ventricle LV throughchordae tendinaea CT (referred to hereinafter “chordae”) which include aplurality of branching tendons secured over the lower surfaces of eachof the valve leaflets LF. The chordae CT in turn, are attached to thepapillary muscles PM, which extend upwardly from the lower wall of theleft ventricle and interventricular septum IVS.

The mitral valve MV comprises a pair of leaflets having free edges FEwhich meet evenly, or “coapt” to close, as illustrated in FIG. 1A. Theopposite ends of the leaflets LF are attached to the surrounding heartstructure via an annular region of tissue referred to as an annulus AN.

FIG. 1A-1 is a schematic cross-sectional side view of tissue of themitral valve MV. The mitral valve MV includes the annulus AN andleaflets LF. Opposite ends of the leaflets LF are attached to thesurrounding heart structure via a fibrous ring of dense connectivetissue of the annulus AN, which is distinct from both the leaflet tissueLF as well as the adjoining muscular tissue of the heart wall. Theleaflets LF and annulus AN are comprised of different types of cardiactissue having varying strength, toughness, fibrosity, and flexibility.Tissue of the annular annulus AN is typically tougher, more fibrous, andstronger than leaflet tissue LF. Furthermore, the mitral valve MV mayalso comprise a unique region of tissue interconnecting each leaflet LFto the annulus AN, referred to herein as leaflet/annulus connectingtissue LAC (indicated by overlapping cross-hatching in FIG. 1A-1). Asubannular surface of the mitral valve MV is a tissue surface lying onthe ventricular side of the plane PO, and preferably one that facesgenerally downstream, toward the left ventricle LV. The subannularsurface may be disposed on the annulus AN itself or the ventricular wallbehind the native leaflets LF, or it may comprise a surface of thenative leaflets LF, either inward-facing IF or outward-facing OF, whichlies below the plane PO. The subannular surface or subannular tissue maythus comprise the annulus AN itself, the native leaflets LF,leaflet/annulus connective tissue, the ventricular wall or combinationsthereof.

FIGS. 1B to 1D show a number of structural defects in the heart cancause mitral valve regurgitation. Ruptured chordae RCT, as shown in FIG.1B, can cause a valve leaflet LF2 to prolapse since inadequate tensionis transmitted to the leaflet via the chordae. While the other leafletLF 1 maintains a normal profile, the two valve leaflets do not properlymeet and leakage from the left ventricle LV into the left atrium LA willoccur, as shown by the arrow.

Regurgitation also occurs in patients suffering from cardiomyopathywhere the heart is dilated and the increased size prevents the valveleaflets LF from meeting properly, as shown in FIG. 1C. The enlargementof the heart causes the mitral annulus to become enlarged, making itimpossible for the free edges FE to meet during systole. The free edgesof the anterior and posterior leaflets normally meet along a line ofcoaptation C as shown in FIG. 1C-1, but a significant gap G can be leftin patients suffering from cardiomyopathy, as shown in FIG. 1C-2.

FIG. 1D shows an impaired mitral valve. Mitral valve regurgitation canalso occur in patients who have suffered ischemic heart disease wherethe functioning of the papillary muscles PM is impaired. As the leftventricle LV contracts during systole, the papillary muscles PM do notcontract sufficiently to effect proper closure. One or both of theleaflets LF1 and LF2 then prolapse, as illustrated. Leakage again occursfrom the left ventricle LV to the left atrium LA, as shown by the arrow.

FIGS. 1C-1, IC-2, and 1E illustrate the shape and relative sizes of theleaflets L of the mitral valve. It may be seen that the overall valvehas a generally kidney-like shape, with a long axis MVA1 and a shortaxis MVA2. In healthy humans the long axis MVA1 is typically within arange from about 33.3 mm to about 42.5 mm in length (37.9+/−4.6 mm), andthe short axis MVA is within a range from about 26.9 mm to about 38.1 mmin length (32.5+/−5.6 mm). However, with patients having decreasedcardiac function these values can be larger, for example MVA1 can bewithin a range from about 45 mm to 55 mm and MVA2 can be within a rangefrom about 35 mm to about 40 mm. The line of coaptation C is curved orC-shaped, thereby defining a relatively large anterior leaflet AL andsubstantially smaller posterior leaflet PL (FIG. 1C-1). Both leafletscan be generally crescent-shaped from the superior or atrial side, withthe anterior leaflet AL being substantially wider in the middle of thevalve than the posterior leaflet. At the opposing ends of the line ofcoaptation C the leaflets join together at corners called theanterolateral commissure AC and posteromedial commissure PC,respectively.

FIG. 1E shows the shape and dimensions of the annulus AN. The annulus ANis an annular area around the circumference of the valve and maycomprise a saddle-like shape with a first peak portion PP1 and a secondpeak portion PP2 located along an interpeak axis IPD, and a first valleyportion VP1 and a second valley portion VP2 located along an intervalleyaxis IVD. The first and second peak portions PP1 and PP2 are higher inelevation relative to a plane containing the nadirs of the two valleyportions VP1, VP2, typically being about 8 mm to about 19 mm higher inhumans, thus giving the valve an overall saddle-like shape. The distancebetween the first and second peak portions PP1, PP2, referred to asinterpeak span IPD, is substantially shorter than the intervalley spanIVD, the distance between first and second valley portions VP1, VP2. Thedimensions and physiology of the patient may vary among patients, andalthough some patients may comprise differing physiology, the teachingsas described herein can be adapted for use by many patients havingvarious conditions, dimensions and shapes of anatomical structures. Forexample, some patients may have a long dimension across the annulus anda short dimension across the annulus of the mitral valve without welldefined peak and valley portions, and the methods and apparatus asdescribed herein can be configured accordingly.

Access to the Delivery Sites

Access to treatment sites can be provided by various techniques andprocedures. For example, minimally invasive surgery techniques,laparoscopic procedures, and/or open surgical procedures can provideaccess to treatment sites in the heart. In procedures targeting valves,minimally invasive surgery techniques may be percutaneous procedures inwhich access can be accomplished through the patient's vasculature.Percutaneous procedures refer to procedures in which a location of thevasculature remote from the heart is accessed through the skin, oftenusing a surgical cut down procedure or a minimally invasive procedure,such as using needle access through, for example, the Seldingertechnique. The ability to percutaneously access remote vasculature iswell-known and described in patent literature and medical literature.For example, the approach to a mitral valve may be antegrade and mayrely on entry into the left atrium by crossing the interatrial septum.Alternatively, the approach to the mitral valve can be retrograde wherethe left ventricle is entered through the aortic valve.

Using a transeptal approach, access to the mitral valve can be obtainedvia the interior vena cava IVC or superior vena cava SVC, through theright atrium RA, across the interatrial septum IAS and into the leftatrium LA above the mitral valve MV. As shown in FIG. 1F, a catheter 10having a needle 12 may be advanced from the inferior vena cava IVC intothe right atrium RA. Once the catheter 10 reaches the anterior side ofthe interatrial septum IAS, the needle 12 may be advanced so that itpenetrates through the septum, for example at the fossa ovalis FO or theforamen ovale into the left atrium LA. At this point, a guidewire may beexchanged for the needle 12 and the catheter 10 withdrawn.

As shown in FIG. 1G, access through the interatrial septum may usuallybe maintained by the placement of a guide catheter 14 (e.g., a steerablecatheter, a guide sheath, etc.), typically over a guidewire 16 which hasbeen placed as described above. The guide catheter 14 affords subsequentaccess to permit introduction of a catheter to treat the mitral valve,as described in more detail below.

The antegrade or transseptal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, the use of theantegrade approach may allow for more precise and effective centeringand stabilization of the guide catheter and/or prosthetic device (e.g.,a prosthetic heart valve). Precise positioning facilitates accuracy inthe placement of the prosthetic valve apparatus. The antegrade approachmay also reduce the risk of damaging the subvalvular apparatus duringcatheter and interventional tool introduction and manipulation.Additionally, the antegrade approach may decrease risks associated withcrossing the aortic valve as in retrograde approaches. This can beparticularly relevant to patients with prosthetic aortic valves, whichcannot be crossed at all or without substantially risk of damage.

An example of a retrograde approach to the mitral valve is illustratedin FIGS. 1H and 1I. The mitral valve MV may be accessed by an approachfrom the aortic arch AA, across the aortic valve AV, and into the leftventricle below the mitral valve MV. The aortic arch AA may be accessedthrough a conventional femoral artery access route, as well as throughmore direct approaches via the brachial artery, axillary artery, or aradial or carotid artery. Such access may be achieved with the use of aguidewire 16. Once in place, a guide catheter 14 may be tracked over theguidewire 16 (FIG. 1H). The guide catheter 14 affords subsequent accessto permit placement of the prosthetic device, as described in moredetail below. In some instances, a retrograde arterial approach to themitral valve can be preferred due to its advantages. Use of theretrograde approach can eliminate the need for a trans-septal puncture.The retrograde approach is also commonly used by cardiologists and thushas the advantage of familiarity.

An additional approach to the mitral valve is via trans-apical puncture,as shown in FIG. 1J. In this approach, access to the heart can be gainedvia thoracic incision, which can be a conventional open thoracotomy orsternotomy, or a smaller intercostal or sub-xyphoid incision orpuncture. An access device (e.g., a cannula, a guide catheter, etc.) isthen placed through a puncture, sealed by a purse-string suture, in thewall of the left ventricle near the apex of the heart. The catheters andprosthetic devices disclosed herein may then be introduced into the leftventricle through this access cannula. The trans-apical approach canhave the advantage of providing a shorter, straighter, and more directpath to the mitral valve or aortic valve. Further, because it does notinvolve intravascular access, it can be performed by surgeons who maynot have the necessary training in interventional cardiology to performthe catheterization of other percutaneous approaches.

Once access to the valve is achieved, the interventional tools andcatheters may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners. In someembodiments, access to a delivery site can be through the chest of thepatient and may be provided by, for example, conventional transthoracicsurgical approaches, open and semi-open heart procedures, laparoscopictechniques, and port access techniques. Such surgical access andprocedures can utilize conventional surgical instruments, including, forexample, retractors, rib spreaders, trocars, laparoscopic instruments,forceps, scissors, shears, rongeurs, fixation devices (e.g., clipappliers, clamps, etc.), staplers, sutures, needle holders, cauterizinginstruments, electrosurgical pens, suction apparatuses, approximators,and/or the like.

At least some catheters disclosed herein can deploy prosthetic devicesas an adjunct to a surgical heart procedure (e.g., coronary arterybypass surgery, replacing and/or repairing portions of the heart, etc.),such that one or more prosthetic devices can be delivered withoutperforming additional complicated procedures for gaining access to thetreatment site. For example, in one surgical procedure, a heart valverepair procedure (e.g., aortic valve repair, mitral valve repair,pulmonary valve repair, etc.) may be performed on one valve and valvereplacement may be performed on another heart valve (e.g., a diseasedaortic valve, a mitral valve, a pulmonary valve, etc.).

The catheters and/or prosthetic devices disclosed herein may beconfigured for a particular approach or interchangeable amongapproaches. A person of ordinary skill in the art can identify anappropriate approach for an individual patient and design the treatmentapparatus for the identified approach in accordance with embodimentsdescribed herein. For example, an intravascular catheter can beflexible, while a transapical catheter can be generally rigid. Theproperties, dimensions (e.g., width, length, etc.), and configuration ofthe catheter can be selected based on the delivery approach. In someembodiments, the catheter can include one or more lumens for aspiratingfluid (e.g., air, blood, etc.) from a delivery capsule. In someprocedures, the lumens can be used to de-air the catheter prior tointroduction to the patient's body.

A wide range of surgical instruments can be used to access the heart,perform surgical procedures on the heart, and assist in operation of acatheter capable of delivering a prosthetic device in the heart. Suchsurgical instruments include, without limitation, sizing rings,balloons, calipers, gages, and other surgical tools can be selectedbased on, for example, desired access path, dimensions and configurationof the delivery apparatuses, and an anatomical structure of the heart.Orientation and steering of the treatment apparatuses (e.g., catheters)can be combined with many known catheters, tools, and devices. Suchorientation may be accomplished by gross steering of the treatmentapparatus to the desired location and then refined steering of thecomponents of the treatment apparatus to achieve a desired result.

Steering may be accomplished by a number of suitable methods. Forexample, a steerable guidewire may be used to introduce a guide catheterand a catheter for delivering a prosthetic device into the properposition. The guide catheter may be introduced, for example, using asurgical cut down of Seldinger access to the femoral artery in thepatient's groin. After placing a guidewire, the guide catheter may beintroduced over the guidewire to the desired position. Alternatively, ashorter and differently shaped guide catheter could be introducedthrough the other routes described above.

A guide catheter may be pre-shaped to provide a desired orientationrelative to the treatment site. For access to the native mitral valvevia the trans-septal approach, the guide catheter may have a curvedshape, an angled configuration, or other suitable shape at its tip toorient the distal end toward the mitral valve from the location of theseptal puncture through which the guide catheter extends. For theretrograde approach, as shown in FIGS. 1H and 1I, guide catheter 14 mayhave a pre-shaped J-tip which is configured so that it turns toward themitral valve MV after it is placed over the aortic arch AA and throughthe aortic valve AV. As shown in FIG. 1H, the guide catheter 14 may beconfigured to extend down into the left ventricle LV and to evert sothat the orientation of an interventional tool or catheter is moreclosely aligned with the axis of the mitral valve MV. In either case, apre-shaped guide catheter may be configured to be straightened forendovascular delivery by means of a stylet or stiff guidewire which ispassed through a lumen of the guide catheter. The guide catheter mightalso have pull-wires or other features to adjust its shape for more finesteering adjustment.

Treatment of Cardiac Valves

FIG. 2A is a schematic cross-sectional illustration of a heart and adelivery capsule of a catheter delivered via a trans-apical approach tothe mitral valve. FIG. 2B shows the delivery capsule in a deploymentconfiguration and a deployed prosthetic device. Referring first to FIG.2A, a system 100 can include a guide catheter 110 and a catheter 102extending through the guide catheter 110. The guide catheter 110 ispositioned in a trans-apical opening 114 to provide access to the leftventricle LV. The catheter 102 can include a hydraulically actuatabledelivery capsule 122 (“delivery capsule 122”) and an elongated catheterbody 124 (“catheter body 124”). The delivery capsule 122 may bepositioned between a posterior leaflet 130 and an interior leaflet 134of a mitral valve 140. The catheter body 124 can be conveniently movedin the superior direction (as indicated by arrow 166) and the inferiordirection (as indicated by arrow 168) to position the delivery capsule122 at a desired location within an opening 160 of the mitral valve 140.

The delivery capsule 122 can be hydraulically driven from a containmentconfiguration (FIG. 2A) towards a deployment configuration (FIG. 2B) todeploy a prosthetic device 150, such as a prosthetic heart valve (theprosthetic device 150 is shown schematically in dashed lines). Thedelivery capsule is expected to reduce, limit, or substantiallyeliminate uncontrolled movement of the prosthetic device 150 caused byforces associated with expansion of the prosthetic device 150. Suchuncontrolled movement can include, for example, axial jumping,self-ejection, or other types of uncontrolled movement. For example, thedelivery capsule 122 is expected to inhibit or prevent translation ofthe prosthetic device 150 while at least a portion of the prostheticdevice 150 expands to contact the treatment site.

A biasing force provided by a biasing device can limit or substantiallyprevent opening of the delivery capsule 122 attributable to the forcesproduced by the prosthetic device 150. For example, unsheathed portionof the prosthetic device 150 can expand outwardly from the partiallyopened delivery capsule 122 while biasing device inhibits furtheropening of the delivery capsule 122. In some embodiments, for example,the delivery capsule 122 can be hydraulically driven towards thedeployment configuration in a controlled manner to deploy the prostheticdevice 150 at the treatment site. Further details regarding the deliverycapsule 122 are provided below.

Referring to FIG. 2B, the prosthetic device 150 is in a deployedconfiguration. The opened delivery capsule 122 can now be moved back tothe containment configuration and moved proximally through the deployedprosthetic device 150. The catheter 102 can be pulled proximally throughthe guide catheter 110 and moved from the patient. The catheter 102 canthen be used to deliver additional prosthetic devices or it can bediscarded.

FIG. 3 is an isometric view of the system 100 including the catheter102, a guidewire 208, and a fluid system 206. The fluid system 206 isconfigured to deliver fluid to the catheter 102 to hydraulically operatethe delivery capsule 122. The catheter 102 can include a handheldcontrol unit 210 (“control unit 210”) configured to provide steeringcapability (e.g., 360 degree rotation of the delivery capsule 122, 180degree rotation of the delivery capsule 122, 3-axis steering, 2-axissteering, etc.). In some embodiments, for example, the control unit 210can include a rotational control assembly 214 (“control assembly 214”)and a steering mechanism 216. A knob 224 of the control assembly 214 canbe rotated to rotate the delivery capsule 122 about its longitudinalaxis 230. A knob assembly 240 of the steering mechanism 216 can be usedto steer the catheter 102 by bending a distal portion thereof about atransverse axis. In other embodiments, the control unit 210 may includedifferent features and/or have a different arrangement.

The fluid system 206 can include a fluid source 250 and a line 251coupling the fluid source 250 to the catheter 102. The fluid source 250may contain a flowable substance (e.g., water, saline, etc.) and caninclude, without limitation, one or more pressurization devices, fluidconnectors, fittings, valves, or other fluidic components. Thepressurization devices, for example, can include a pump (e.g., apositive displacement pump, a plunger pump, etc.), a syringe pump (e.g.,a manually operated syringe pump), or other devices capable ofpressurizing the flowable substance. The line 251 can include, withoutlimitation, one or more hoses, tube, or other components (e.g.,connectors, valves, etc.) through which the flowable substance can pass.

In some embodiments, the fluid source 250 may comprise a controller 252including, without limitation, one or more computers, central processingunits, processing devices, microprocessors, digital signal processors(DSPs), and/or application-specific integrated circuits (ASICs). Tostore information, for example, the controller 252 can include, withoutlimitation, one or more storage elements, such as volatile memory,non-volatile memory, read-only memory (ROM), and/or random access memory(RAM). The stored information can include, pumping programs, patientinformation, and/or executable programs. The controller 252 can furtherinclude a manual input device (e.g., a keyboard, a touch screen, etc.)or an automated input device (e.g., a computer, a data storage device,servers, network, etc.). In still other embodiments, the controller 252may include different features and/or have a different arrangement.

FIG. 3 shows the catheter 102 traveling over the guidewire 208. Theguidewire 208 includes a proximal portion 260, a distal portion 262, anda main body 264. The proximal portion 260 extends proximally from thecontrol assembly 214, and the distal portion 262 extends distally pastthe delivery capsule 122. As discussed in greater detail below withreference to FIG. 11, the guidewire 208 can be used to guide thedelivery capsule 122 into the native heart valve.

FIG. 4 is an isometric view of a distal portion of the catheter 102configured in accordance with various embodiments of the presenttechnology. The delivery capsule 122, for example, can include a housing268 configured to hold the prosthetic device 150 (shown schematically inbroken lines). The housing 268 can include a distal sheath 270 and aproximal sheath 272. The distal sheath 270 can include a closed distalend 274 and a distal containment portion 275. The distal end 274 canhave a guidewire-receiving opening 276 and can have an atraumaticconfiguration (e.g., a substantially partially spherical shape, bluntconfiguration, rounded configuration, etc.) to limit or prevent injuryor trauma to tissue. The distal containment portion 275 can contain adistal portion of the prosthetic device 150.

The proximal sheath 272 can include a proximal containment portion 284,a tapered portion 287, and a guide portion 290. The proximal containmentportion 284 can contain a proximal portion of the prosthetic device 150and can mate with the distal containment portion 275. The taperedportion 287 can have a frusto-conical shape, a partially sphericalshape, or other suitable configuration for substantially preventing orlimiting injury or trauma to tissue when the delivery capsule 122 ispulled proximally through the subject. The guide portion 290 can closelysurround the catheter body 124.

The distal sheath 270 and/or proximal sheath 272 can be made, in wholeor in part, of metal, polymers, plastic, composites, combinationsthereof, or other materials capable of holding the prosthetic device150. In some embodiments, the distal containment portion 275 can be atubular member (e.g., a tubular portion with a generally circular crosssection, a generally elliptical cross section, etc.) made of metal orother rigid materials. In some embodiments, the distal sheath 270 orproximal sheath 272 can be configured to contain the entire valveprosthetic device 150.

FIG. 5 is an exploded isometric view of the distal portion of thecatheter 102. As best seen in FIG. 5, the delivery capsule 122 caninclude a piston device 292 and a biasing device 294. The piston device292 can include a distal head assembly 300, a proximal head assembly304, and a connector 310. The connector 310 can include ends 330, 350connected to the distal and proximal head assemblies 300, 304,respectively.

The distal head assembly 300 can include a head 320 and a sealing member322. The head 320 can include a through-hole 331 and a channel 332 forreceiving the sealing member 322. The proximal head assembly 304 caninclude a head 340 and a sealing member 342. The head 340 can include achannel 352 for receiving the sealing member 342 and a holder 360.

The holder 360 is configured to retain the prosthetic device 150 and caninclude a hub 362 and retaining features in the form of posts 364 a, 364b, 364 c (collectively “posts 364”). The posts 364 are circumferentiallyspaced apart about the hub 362. In the illustrated embodiment, the threeposts 364 extend radially outward. In other embodiments, however, thenumbers of posts 364 can be increased or decreased and the posts 364 maybe arranged evenly or unevenly about the hub 362. When the prostheticdevice 150 is in a delivery configuration (e.g., a collapsed state, anundeployed state, etc.), the posts 364 can pass through receivingfeatures (e.g., openings, holes, eyelets, etc.) of the prosthetic device150 to inhibit, prevent, or substantially eliminate movement of theprosthetic device 150 along the longitudinal axis 230 of the deliverycapsule 122.

When being deployed, prosthetic device 150 can radially expand along theposts 364 to move towards a deployed configuration (e.g., an expandedconfiguration). For example, in some embodiments the prosthetic device150 can move past the ends of the posts 364 to disengage the deliverycapsule 122 under its own spring load. In other embodiments, the posts364 can be moved inwardly into the hub 362 to release the prostheticdevice 150. The holder 360 can also include one or more retainingfeatures in the form of hooks, clamps, or other types of featurescapable of holding and releasing a prosthetic device. In otherembodiments, the posts 364 may have a different arrangement relative tothe prosthetic device 150.

The sealing members 322 and 342 are positioned to engage the distal andproximal sheaths 270 and 272, respectively, and can be made, in whole orin part, of silicon, rubber, polymers, elastomers, combinations thereof,or other compliant materials suitable for forming seals. In someembodiments, one or both sealing members 322, 342 are gaskets or O-ringsmade, in whole or in part, of rubber. In yet other embodiments, thesealing members 322, 342 can be bladder seals. Other types of sealingmembers 322, 342 can be used, if needed or desired.

FIG. 5 shows the biasing device 294 carried by the catheter body 124. Asused herein, the term “biasing device” refers generally to one or morebiasing members, such as linear springs, non-linear springs, or otherdevices capable of providing a biasing force. In some embodiments, forexample, the biasing device 294 may comprise a linear spring fordeploying a prosthetic device 150 that produces a substantially constantdeployment forces. In other embodiments, the biasing device 294 maycomprise a non-linear spring for deploying a prosthetic device 150 thatproduces varying deployment forces. The biasing device 294 can be madeof metal, polymers, or combinations thereof. In metal embodiments, thebiasing device 294 can be made, in whole or in part, of steel (e.g.,spring steel), nickel titanium (e.g., nitinol), or other alloys. In oneparticular embodiment, for example, the biasing device 294 is a helicalspring made of nitinol. In yet another embodiment, the biasing member294 is a metal hypotube that has been cut (e.g., laser cut) in a spiralpattern. The biasing device 294 can have a proximal end 372, a distalend 374, and a main body 376. The proximal end 372 can be adjacent ashoulder 380 of the catheter body 124. The catheter body 124 can includea narrowed portion 381 extending through the biasing device 294 and awidened portion 383. The widened portion 383 defines the shoulder 380.The catheter body 124 can be made, in whole or in part, of plastic,thermoplastic elastomers (e.g., resins such as Pebax®), or otherflexible materials. In some embodiments, the catheter body 124 can begenerally rigid for delivery using, for example, a transapical approach.

FIG. 6 is a partially schematic cross-sectional view of the distalposition of the catheter 102 configured in accordance with variousembodiments of the present technology. The distal sheath 270, theproximal sheath 272, and the head assemblies 300, 304 cooperate todefine a containment or main chamber 400. The containment chamber 400 isconfigured to contain the prosthetic device 150. Equal parts of thecontainment chamber 400 may be disposed in the distal sheath 270 andproximal sheath 272, or the containment chamber 400 may have a largerportion or even its entirety contained in either the distal or proximalsheath. The sealing member 322 is positioned to sealingly engage thedistal sheath 270 to form a fluid chamber 410 (e.g., a fluidicallysealed chamber or an isolated fluid chamber). The sealing member 342 ispositioned to sealingly engage the proximal sheath 272 to form a fluidchamber 412. The fluid chambers 410, 412 can be fluidically sealed fromthe containment chamber 400. A flowable substance can be delivered intothe fluid chamber 410 to move the distal sheath 270 in the distaldirection (indicated by arrow 416) to unsheathe an upstream or atrialportion 424 of the prosthetic device 150. Fluid can be delivered intothe fluid chamber 412 to move the proximal sheath 272 in the proximaldirection (indicated by arrow 418) to unsheathe a downstream orventricular end or portion 426 of the prosthetic device 150.

The distal end 274 of the distal sheath 270 can include a wall 440 and apassageway 444. A rod 450 can be positioned in at least a portion of thepassageway 444. The rod 450 can include, for example, a distal end 451coupled to the distal sheath 270 and a retaining head 530 positioned ina lumen 454 of the piston device 294. Although not illustrated, the rod450 can be hollow to receive a guidewire. The distal containment portion275 includes a proximal open end 432 and a cylindrical sidewall 460. Thecylindrical sidewall 460 can include an inner surface 462 and an outersurface 464. The sealing member 322 can physically contact the innersurface 462 to form a seal (e.g., an airtight seal, a fluid-tight seal,etc.).

As best seen in FIG. 6, the proximal containment portion 284 of theproximal sheath 272 can include a distal open end 470 and a closedproximal end 472. The distal open end 470 is received by the proximalopen end 432 of the distal sheath 270. In some embodiments, a seal maybe formed by the distal open end 470 and the proximal open end 432. Theguide portion 290 of the proximal sheath 272 has a sidewall 488 thatdefines a lumen 490. The proximal sheath 272 can further include a stop496 extending inwardly into the lumen 490. When the proximal sheath 272is moved proximally (as indicated by arrow 418), the stop 496 cancontact the biasing device 294.

The narrowed portion 381 of the catheter body 124 extends through thebiasing device 294 and can include one or more ports 500 (one port 500is identified in FIG. 6). Fluid can flow along a fluid lumen 388,through the port(s) 500, and into the fluid chamber 412. The number,sizes, and positions of the ports 500 can be selected to achieve thedesired flow into the fluid chamber 412. A seal between the stop 496 andthe narrowed portion 381 and/or a seal 509 between the guide portion 290and the widened portion 383 can help achieve the desired fluid pressurein the chamber 412.

Although not illustrated, the catheter body 124 can include multiplelumens. One fluid lumen, for example, can provide fluid communicationwith fluid chamber 410, and another fluid lumen can provide fluidcommunication with the fluid chamber 412. Fluid can be independentlydelivered into and removed from the respective fluid chambers 410, 412.In some embodiments, fluid at a first pressure can be delivered into thefluid chamber 410 to move the distal sheath 270. At the same or adifferent time, fluid at a second pressure can be delivered into thefluid chamber 412 to move the proximal sheath 272. The second pressurecan be equal to or different from the first pressure.

FIG. 7 is a partially schematic cross-sectional view of the control unit210 of FIG. 3. The control unit 210 can further include an articulationmechanism 218. The articulation mechanism 218 includes a slider assembly519 and a coupler 520. The slider assembly 519 can include a rod 518 anda knob 521. The rod 518 can have external threads that threadably engageinternal threads of a threaded container 527. A pull wire 523 can couplethe coupler 520 to the catheter body 124 such that rotation of the knob521 about an axis of rotation 525 causes axial movement of the rod 518.The rod 518 can be moved distally or proximally to decrease or increase,respectively, the tension in the pull wire 523 to articulate thecatheter 102. In some embodiments, the pull wire 523 can be tensionedto, for example, bend the catheter body 124 up or down. Alternatively,the pull wire 523 can be tensioned to bend or articulate the catheterbody 124 in other directions.

A tubular member 531 can be coupled to the catheter body 124 and theknow 224 (FIG. 3). A locking feature (e.g. a screw, a fastener, or thelike) is configured to releasably engage the tubular member 531. Forexample, the locking feature 529 can be in a locked position to securelyhold the tubular member 531 to prevent rotation of the catheter body124. The locking feature 529 can be moved to an unlocked position toallow rotation of the tubular member 531 and the catheter body 124. Inother embodiments, the locking feature 529 can have a differentarrangement and/or different features.

FIG. 8 is a detailed cross-sectional view of a connector assembly 533configured for use with the control unit of FIG. 7. The connectorassembly 533, for example, can include a junction 534 and a swivelingmember 538. The junction 523 is configured to fluidically couple theline 251 to the catheter body 124. The line 251 is coupled to an inlet537 of the junction 534. The swiveling member 538 can rotatably couplesthe catheter body 124 to a housing 517.

FIG. 9 is a cross-sectional view of the control unit 210 with knobassemblies 240 a, 240 b (collectively “knob assemblies 240”) taken alongline 9-9 of FIG. 7. The knob assemblies 240 can be operated to move thedelivery capsule 122. For example, the knob assembly 240 a can berotated to move the delivery capsule 122 to the right, and the knobassembly 240 b can be rotated to move the delivery capsule 122 to theleft. The knob assemblies 240 can be used to bend the catheter body 124to the left or right, while the articulation mechanism 218 can be usedto move bend the catheter body 124 up or down. The knob assemblies 240can be generally similar to each other and, accordingly, the descriptionof one knob assembly applies equal to the other knob assembly, unlessindicated otherwise. In other embodiments, the knob assemblies 240 mayinclude different features and/or have a different arrangement to, forexample, controllably move the catheter body 124 in opposite directions.

The knob assemblies 240 a, 240 b may be coupled to the catheter body 124via pull wires 542 a, 542 b, respectively. The knob assembly 240 aincludes a knob 543 a coupled to a pulley 545 a. The wire 542 a iswrapped around the pulley 545 a such that rotation of the knob 543 a canincrease or decrease the length of the pull wire 542 a, extending fromthe pulley 545 a. For example, the knob 543 a can be rotated to wrap thewire 542 a around the pulley 545 a to increase the tension in the wire542 a. The knob 543 a can be rotated in the opposite direction to unwindthe wire 542 a from the pulley 545 a to decrease the tension in the wire542 a. The control unit 210 can further include a stress-relief feature516 coupled to the housing 517. The stress-relief feature 516, forexample, may be configured to surround the catheter body 124 and can bemade of a flexible material. In other embodiments, however, the controlunit 210 may not include the stress-relief feature 516 or thestress-relief feature 516 may include different features.

FIG. 10 is a cross-sectional view of the control assembly 214 of FIG. 3.The control assembly 214 can include a sealing assembly 548 and the knob224. The knob 224 can be fixedly coupled to the tubular member 531. Theknob 224, for example, can be rotated about an axis of rotation 546 tocause corresponding rotation of the tubular member 531. In otherembodiments, the control assembly 214 can include different featuresand/or have different features.

FIGS. 11-14 are a series of views of a method of deploying theprosthetic device 150. As described in greater detail below, thedelivery capsule 122 is configured to be positioned within the patient'smitral valve 140. The distal sheath 270 can be hydraulically driven tounsheathe the atrial end 424 of the prosthetic device 150. Theunsheathed atrial end 424 can move outwardly to engage the tissue of themitral valve 140 while the delivery capsule 122 holds the ventricularend 426 of the prosthetic device 150. The proximal sheath 272 can behydraulically driven to unsheathe the ventricular end 426 of theprosthetic device 150. The unsheathed ventricular end 426 can moveoutwardly to engage the tissue of the mitral valve 140.

FIG. 11, for example, shows an opening 510 formed at the apex 512 of theheart H to access the left ventricle LV. The opening 510 can be anincision formed by, for example, a needle, a cutting tool, or a catheter(e.g., a needle catheter). The guide catheter 110 can be moved distallythrough the opening 510 and into the left ventricle LV. After the guidecatheter 110 is positioned in the opening 510, the guidewire 208 can bemoved through the guide catheter 110 and positioned between theposterior and anterior leaflets 130, 134. The distal portion 262 of theguidewire 208 can be moved into the left atrium LA. In some embodiments,the distal portion 262 can be an atraumatic tip (e.g., a flexible tip, acurved tip, a rounded tip, etc.) to prevent, inhibit, or substantiallyprevent injury to the heart tissue.

In the arrangement illustrated in FIG. 11, the delivery capsule 122 isready to be moved between the posterior and anterior leaflets 130, 134.The delivery capsule 122 can be advanced over the guidewire 208 whilethe mitral valve 140 opens and closes. When the mitral valve 140 isclosed (as shown in FIG. 11), the posterior and anterior leaflets 130,134 can seal around the guidewire 208. Further, when the mitral valve140 opens, the guidewire 208 can be conveniently advanced through themitral valve 140.

FIG. 12 shows the delivery capsule 122 positioned between the posteriorand anterior leaflets 130, 134. A position indicator (e.g., in the formof a marker 501) may be carried on the proximal sheath 272. For example,the delivery capsule 122 can be rotated about its longitudinal axis 220to align the marker 501 with the mitral valve 140. Markers can belocated on an exterior surface of the distal sheath 270, on an exteriorsurface of the proximal sheath 272, within internal components of thedelivery capsule 122, or at other suitable locations. In someembodiments, markers can be resonant markers for MR imaging-guideddelivery. In yet further embodiments, markers can be echocardiographicmarkers viewable under echocardiography. Other types of markers can beused. In some procedures, a posterior side of the prosthetic device 150can be aligned with the posterior leaflet 130 using a marker on aposterior side of the delivery capsule 122. Additionally oralternatively, a marker on an anterior side of the delivery capsule 122can be used to align the anterior side of the delivery capsule 122 withthe anterior leaflet 134.

FIG. 12 further illustrates the prosthetic device 150 ready to bedeployed. For example, the fluid system 206 (FIG. 3) is configured todeliver fluid into the catheter 102, and the fluid can flow distallyalong the fluid lumens 388, 524 and into the chamber 410. The fluidfills the chamber 410 and causes movement of the distal sheath 270 inthe distal direction. Friction, if any, between the prosthetic device150 and the distal sheath 270 may cause pulling on the prosthetic device150. However, the delivery capsule 122 is configured to hold theprosthetic device 150 to prevent, for example, inadvertent distalmovement of the prosthetic device 150. The distal sheath 270 can beadvanced distally until the head 530 contacts stops 532.

FIG. 13 shows the distal sheath 270 after it has been moved to an openor deployed position. The unsheathed atrial end 424 of the prostheticdevice 150 has moved (as indicated by arrows) through an opening 540 toallow the atrial end 424 to radially expand. An atrial rim 427 of theatrial end 424 can expand to its fully deployed configuration (shown) toengage native heart tissue around the circumference (e.g., most of orthe entire circumference) of the mitral valve 140. In some procedures,the atrial rim 427 can contact the native annulus AN, tissue proximateto the native annulus AN either in the atrium or ventricle, the nativevalve leaflets, and/or other tissue suitable for contacting theprosthetic device 150. For example, the atrial rim 427 can contact theleaflet/annulus connecting tissue and tissue of the leaflets proximateto the native annulus AN. In self-expanding embodiments, the radiallyunrestrained atrial end 424 expands upon unsheathing. In otherembodiments, expanders can be used to expand the unsheathed atrial end424. For example, an expander in the form of a balloon can be positionedwithin the prosthetic device 150 and can be inflated to deploy theatrial end 424.

The delivery capsule 122 is expected to substantially prevent axialmovement of the prosthetic device 150. For example, the holder 360 canprevent translation of the sheathed portion of the prosthetic device 150while the atrial end 424 expands. In some embodiments, the expandedportion of the prosthetic device 150 may pull on the sheathed portion ofthe prosthetic device 150. The prosthetic device 150 would deploy in anuncontrolled manner but for the holder 360 restraining axial translationof the prosthetic device 150. In some embodiments, the holder 360 canhold the proximal sheath 272 substantially stationary relative to themitral valve 140. As shown in FIGS. 12 and 13, the axial position of theprosthetic device 150 can be maintained throughout expansion of theatrial end 424.

Additionally, the force exerted by the biasing device 294 can besufficient to prevent uncontrolled movement of the proximal sheath 272in the proximal direction. For example, the partially expandedprosthetic device 150 of FIG. 13 may contact and apply a force component(e.g., an axially directed force component, a proximally-directed forcecomponent, etc.) to the distal end 470 of the proximal sheath 272. Thecompressed biasing device 294 can urge the proximal sheath 272 in thedistal direction to counteract the force component. The biasing device294 can thus inhibit, limit, or substantially prevent movement of theproximal sheath 272 in the proximal direction caused by the prostheticdevice 150. The characteristics (e.g., spring constant, applied forceversus deflection curve, etc.) of the biasing device 294 can be selectedbased on the forces that will be produced by the prosthetic device 150.Linear springs can be used with, for example, prosthetic devices thatproduce substantially constant deployment forces (e.g., substantiallyconstant proximally-directed force component). Non-linear springs can beused with, for example, prosthetic devices that produce varyingdeployment forces.

In some embodiments, the biasing device 294 can provide a variableforce. The variable force can be generally maximum when the forces fromthe prosthetic device 150 pushing on the delivery capsule 122 arehighest and resistance between the delivery capsule and the prostheticdevice is lowest. As the prosthetic device 150 is unsheathed from thedelivery capsule 122, a greater and greater portion of the prostheticdevice is exposed outside the delivery capsule and the forces exerted bythe exposed portion of the prosthetic device urging the delivery capsuleto the open configuration are increasing. At the same time, the surfacearea of the prosthetic device 150 remaining in the delivery capsule 122is decreasing, thus reducing the frictional resistance between theprosthetic device 150 and the delivery capsule 122. Thus, in someembodiments, the force exerted by the biasing device 294 increases asthe prosthetic device 150 is unsheathed. In some embodiments, biasingdevice 294 can be a spring which applies a force that increases withspring displacement. In some embodiments, the biasing device 294 caninclude plurality of springs. For example, one spring can have a lowspring constant to counteract low forces applied by the prostheticdevice 150 to the delivery capsule 122. Another spring can have arelative large spring constant to counteract high forces applied by theprosthetic device 150 to the delivery capsule 122. In some embodiments,the biasing device 294 can be offset such that the distal sheath 270and/or proximal sheath 272 can be moved a predetermined distance beforethe biasing device begins to apply a force. One of the distal sheath 270and the proximal sheath 272 can be moved a short distance (e.g., 1 mm-5mm) before a first spring (e.g., a spring with a low spring constant)begins to deform. A second spring (e.g., a spring with a high springconstant) of the biasing device 294 can begin to deform as the deliverycapsule 122 approaches the deployed configuration. The number andproperties of the springs can be selected to achieve the desireddeployment of the prosthetic device 150.

FIG. 13 shows the proximal sheath 272 in a closed position. Duringoperation, fluid can flow along the lumen 388, through the ports 500,and into the chamber 412. The fluid pressure in the chamber 412 canincrease until the fluid pressure causes proximal movement of theproximal sheath 272. When the pressure in the fluid chamber 412overcomes the biasing force of the biasing device 294, the proximalsheath 272 can move proximally, thereby compressing the biasing device294. In some embodiments, the distance of travel of the proximal sheath272 can be generally proportional to the fluid pressure in the chamber412 such that the fluid pressure in the chamber 412 can be increased tocontrollably move the proximal sheath 272.

In some embodiments, the prosthetic device 150 (in an expandedconfiguration) comprises a generally frusto-conical, bell, or otherflared shape. In particular, the atrial end 424 can have a diameter thanis greater than the diameter of the downstream or ventricular end 426 inan unrestrained deployed configuration. For example, the atrial end 424may produced a first force generally in the proximal direction when theatrial end 424 exits the opening 540. When the ventricular end 426 exitsthe proximal sheath 272, it may produce a second force generally in theproximal direction. In this embodiment, the prosthetic device 150interacts with the distal and proximal sheaths such that the first forceis greater than the second force. In other embodiments, the prostheticdevice 150 can have generally tubular shape and a uniform diameter alongits length when in its delivery configuration and when in its expandedconfiguration. In still other embodiments, the prosthetic device 150 mayhave other arrangements.

After the distal end 470 of the proximal sheath 272 moves proximallypast the ventricular end 426 of the prosthetic device 150, theventricular end 426 can move radially outward from the posts 364 tocontact the posterior and anterior leaflets 130, 134. FIG. 14, forexample, shows the prosthetic device 159 after its entire axial lengthhas been unsheathed. The prosthetic device 150 can include, withoutlimitation, one or more anchoring members that engage the native valve140 so as to, for example, resist systolic forces, prevent upstreammigration of the prosthetic device 150, etc. In some embodiments, theprosthetic device is configured to engage subannular tissue of thenative valve 140. Referring to FIG. 1A-1 and FIG. 14 together,“subannular,” as used herein, refers to a portion of the mitral valve140 that lies on or downstream DN (FIG. 1A-1) of the plane PO of thenative orifice. The plate PO (FIG. 1A-1) of the native valve orifice isa place generally perpendicular to the direction of blood flow throughthe valve and which contains either or both the major axis MVA1 or theminor axis MVA2 (FIG. 1E).

The prosthetic device 150 can include upstream anchors configured toengage the inward-facing surfaces IF of the native leaflets 130, 134,which may be pushed outwardly and folded under the native annulus AN.The leaflets 130, 134, for example, can engage a ventricular side of theannulus AN and may be prevented from being pushed further in theupstream direction, thus maintaining the anchoring member below theplane of the native valve annulus. The tissue engaging elements canpenetrate the tissue of the leaflets 130, 134, the annulus AN, and/orother tissue to stabilize and firmly anchor the prosthetic device 150.In some embodiments, some portions of the anchoring members may extendabove the annulus AN, with at least some portions of the anchoringmember engaging tissue in a subannular location to prevent migration ofthe prosthetic device 150 toward the left atrium LA. The prostheticdevice 150 is configured to conform to the irregularly-shaped mitralannulus AN, effectively scaling the prosthetic device 150 against thenative annulus AN to anchor the prosthetic device 150 and to preventparavalvular leaks. The prosthetic device 150, for example, can be aprosthetic device (e.g., a prosthetic heart valve device) such as one ormore of the prosthetic devices disclosed in (1) International PCT PatentApplication No. PCT/US2012/043636, entitled “PROSTHETIC HEART VALVEDEVICES AND ASSOCIATED SYSTEMS AND METHODS,” filed on Jun. 21, 2012; (2)U.S. Provisional Patent Application No. 61/549,037, entitled “SYSTEM FORMITRAL VALVE REPLACEMENT,” filed on Oct. 19, 2011; (3) U.S. ProvisionalPatent Application No. 61/605,699, entitled “SYSTEM FOR MITRAL VALVEREPLACEMENT,” filed on Mar. 1, 2012; and (4) International PCT PatentApplication No. PCT/US2012/061215, entitled “DEVICES, SYSTEMS ANDMETHODS FOR HEART VALVE REPLACEMENT,” filed on Oct. 19, 2012. Each ofthese references is incorporated by reference in its entirety. Forexample, the delivery catheters disclosed herein can include a sheathcontaining a prosthetic device. The sheath can be a split-sheathincluding, without limitation, a distal nose cone and a proximalcapsule, as disclosed in U.S. Provisional Patent Application No.61/605,699, entitled “SYSTEM FOR MITRAL VALVE REPLACEMENT,” filed onMar. 1, 2012. The delivery catheter can also include other features(e.g., sheaths, tethers, pistons, stops, cables, etc.) disclosed in U.S.Provisional Patent Application No. 61,605,699, entitled “SYSTEM FORMITRAL VALVE REPLACEMENT,” filed on Mar. 1, 2012 or other referencesincorporated by reference in their entirety. It will also beappreciated, however, that other types of prosthetic devices can also bedeployed by the delivery capsule.

In the illustrated embodiment, a distance of travel D_(D) of the distalsheath 270 can be substantially less than an axial length L of theprosthetic device 150. For example, the distance of travel D_(D) can beless than about 70%, 60%, or 50% of the length L of the prostheticdevice 150. In other embodiments, however, the distance of travel D_(D)may have different values relative to the length L of the prostheticdevice 150. In some embodiments, each sheath 270, 272 can contain abouthalf of the prosthetic device 150. Distances of travel D_(D), D_(P) ofthe sheaths 270, 272 can be generally equal, such that the sheaths 270,272 can move into the left atrium LA and the left ventricle LV,respectively, without contacting the wall of the heart. In particularembodiments, the distal sheath 270 can unsheathe about 8 mm to about 16mm of the prosthetic device 150, and the proximal sheath 272 canunsheathe about 8 mm to about 16 mm of the prosthetic device 150. Thelength L, for example, can be about 16 mm to about 32 mm. In otherembodiments, however, the sheaths 270, 272 may be configured tounsheathe more or less of the prosthetic device 150 and/or the length Lcan vary.

With continued reference to FIG. 14, the delivery capsule 122 can bereturned to the containment configuration. In particular, fluid can flowout of the chamber 412 and proximally through the lumen 388, and thebiasing device 294 can urge the proximal sheath 272 back to the closedposition. Additionally, fluid can flow out of the chamber 410 to movethe distal sheath 270 back to the closed position. In some embodiments,a vacuum is drawn to draw fluid from one or both chambers 410, 412.Additionally or alternatively, one or more biasing devices can move thedistal sheath 270.

After the delivery capsule 122 is moved to the containmentconfiguration, it can be pulled proximally through the deployedprosthetic device 150 and into the left ventricle LV. The deliverycapsule 122 can be pulled into the guide catheter 110 and removed fromthe subject. Other techniques can be used to remove the catheter 102from the heart.

The method discussed above in connection with FIGS. 11-14 can bemodified to delivery the prosthetic device 150 via trans-septal orretrograde approaches. For example, the length of the catheter body 124,dimensions of the delivery capsule 122, and steerability of the catheter102 can be selected based on a selected delivery path (e.g., via theaortic valve, via the venous vasculature, etc.). Additionally, varioustypes of visualization techniques can be used with the method discussedin connection with FIGS. 11-14. For example, visualization can be usedto help deliver, position, operate, and/or remove the catheter 102. Forexample, fluoroscopy, computer tomography (CT), magnetic resonanceimaging (MRI), ultrasound, or other imaging techniques can help evaluatean access path, delivery path, treatment site, and position of thecatheter 102 and/or prosthetic device 150 before, during, and/or afterdelivery of the prosthetic device 150.

FIGS. 15-17 are a series of views of a method of deploying a prostheticdevice from a delivery capsule 600 in accordance with variousembodiments of the present technology. The delivery capsule 600 caninclude features and functionality generally similar to the features andfunctionality of delivery capsule 122 discussed in connection with FIGS.2A-14, except as detailed below.

FIG. 15, for example, is a partially schematic cross-sectional viewillustrating the delivery capsule 600 including a mechanicallyactuatable distal sheath 604, a hydraulically actuatable proximal sheath606, and a piston device 610. A prosthetic device 620 (shown in brokenlines) is positioned within a containment chamber 621 that can beisolated from a fluid chamber 684.

The distal sheath 604 can include a main sheath body 640 and a rod 642(e.g., a solid shaft, a hollow shaft, etc.). The main sheath body 640includes a tubular portion 643 and a closed distal end 645. The rod 642can be fixedly coupled to the closed distal end 645 and extends througha lumen 646 of an elongated catheter body 648 (“catheter body 648”). Therod 642 can be moved distally to move the distal sheath 604 from aclosed position (FIG. 15) to an open position (FIG. 16). In someembodiments, the rod 642 can be manually moved. In other embodiments,however, a drive mechanism can move the rod 642. The drive mechanism caninclude, without limitation, a screw drive mechanism, a pneumatic drivemechanism, or other type of mechanism capable of providing linearmotion.

FIG. 16 shows a distal end 650 of the prosthetic device 620 beingunsheathed. For example, the distal end 650 can expand outwardly, asindicated by arrows 670, 672, while the piston device 610 can restrain aproximal end 698 of the prosthetic device 620. After the unsheathedportion of the prosthetic device 620 has expanded, fluid can bedelivered along the lumen 646 and into the chamber 684 to hydraulicallymove the proximal sheath 606 from a closed position (FIG. 16) to an openposition (FIG. 17). In some embodiments, the outer diameter of the rod642 can be slightly smaller than the diameter of the lumen 646 to allowfluid to flow distally along the elongated catheter body 648.Additionally or alternatively, the rod 642 can have one or more flowfeatures, such as channels, recesses, lumens, etc. A biasing device 690can be compressed between a stop 692 and the catheter body 648. After anopen end 699 of the proximal sheath 606 moves proximally past theproximal end 698 of the prosthetic device 620, the proximal end 698 isallowed to move outwardly to a deployed configuration.

FIG. 18 is an isometric view of a catheter 700 for delivering aprosthetic device configured in accordance with another embodiment ofthe present technology. The catheter 700 can include, for example, acontrol unit 701, a delivery capsule 712, and an elongated catheter body714 (“catheter body 714”). The control unit 710 can include an actuationmechanism 716 and an articulation mechanism 719. The actuation mechanism716 can be used to operate the delivery capsule 712. The articulationmechanism 719 can be used to adjust the configuration of anarticulatable region 722 of the catheter body 714.

FIG. 19 is a side view of the control unit 710, and FIG. 20 is across-sectional view of the control unit 710 taken along line 20-20 ofFIG. 19. Referring to FIGS. 19 and 20 together, the actuation mechanism716 can include slider elements 730 a, 730 (collectively “730”) coupledto a tubular member 732 (FIG. 20). The tubular member 732 can extendthrough an outer tubular member 734 of the elongated catheter body 714and can be coupled to a sheath of the delivery capsule 712. The sliderelements 730 can be moved proximally (as indicated by arrows 739 of FIG.20) along elongated slots 744 a, 744 b to move the tubular member 732 inthe proximal direction. Other types of actuation mechanisms can be usedand can include, without limitation, one or more knobs, slots, pullwires, or the like.

FIG. 21 is an exploded isometric view of a distal portion 711 of thecatheter 700 of FIG. 18. The delivery capsule 712, for example, caninclude a distal sheath 720, a piston device 722, and a proximal sheath731. The catheter body 714 can include an inner assembly 741 coupled tothe piston device 722, an intermediate member 742 (e.g., a hollow shaft)coupled to the proximal sheath 731, and the outer member 734. The innerassembly 741 can extend through at least a portion of the intermediatemember 742. In other embodiments, however, the delivery capsule 712 mayinclude different features and/or have a different arrangement.

FIG. 22 is a cross-sectional view of the distal portion 711 of thedelivery capsule 712 of FIG. 21 in a containment configuration. As bestseen in FIG. 22, the distal sheath 720 and the piston device 722 cancooperate to define a fluid chamber 743. The fluid chamber 743 caninclude a rod 764 defining a guidewire lumen 748. A biasing device 746can be coupled to the rod 764 such that displacement of the distalsheath 720 in the distal direction causes compression of the biasingdevice 746.

The distal sheath 720 can include a distal end portion 721, acontainment portion 723, and the rod 764. In multi-piece embodiments,the rod 764 can be a tubular member fixedly coupled to the distal sheath720 by one or more fasteners, adhesive, welding, or the like. Inone-piece embodiments, the distal sheath 720 can be formed by a moldingprocess (e.g., injection molding process, compression molding process,etc.), machining process, or another suitable manufacturing technique.

The piston device 722 can include a head 750, a sealing member 751, anda tubular body 752. The head 750 includes a flange 760 defining anopening 761. The body 752 couples the head 750 to the inner assembly741, which in turn is coupled to the intermediate member 742. The rod764 of the distal sheath 720 extends thought the opening 761 and areceiving slot 754 in the head 750. A biasing device 746 (e.g., aspring) surrounds the rod 764. A mounting region 749 (FIG. 23) of thebiasing device 746 can be fixedly coupled to the rod 764. In otherembodiments, the biasing device 746 may have a different arrangementand/or include different features.

FIGS. 23-25 are a series of views of a method of deploying a prostheticdevice 770. FIG. 23, for example, is a cross-sectional view of thedelivery capsule 712 within the proximal sheath 731 in an open position.FIG. 24 is a cross-sectional view of the delivery capsule 712 with thedistal sheath 720 in an intermediate position, and FIG. 25 is across-sectional view of the delivery capsule 712 in a deploymentconfiguration. Generally, the proximal sheath 731 can be mechanicallydriven to unsheathe a proximal end 772 of a prosthetic device 770, andthe distal sheath 720 can be hydraulically driven to unsheathe a distalend 774 of the prosthetic device 770. Various details of a method ofdeploying the prosthetic device 770 are discussed below.

As described above with reference to FIG. 22, the piston device 722 canhold the prosthetic device 770, and the slider element 730 a (FIG. 20)can be moved to mechanically drive the proximal sheath 731 from a closedposition (FIG. 22) to open position (FIG. 23). More specifically, FIG.23 shows the unsheathed proximal end 772 of the prosthetic device 770ready to expand outwardly through a gap 781, as indicated by arrows 782.The distal end 774 of the prosthetic device 770 can be unsheathed bydelivering fluid distally along a lumen 784 and into the fluid chamber743 via ports 790. In some embodiments, a guidewire may be positioned inthe lumen 748. The fluid can flow distally along the lumen 748 in thespace between the guidewire (not shown) and the rod 764. In otherembodiments, the guidewire can be removed from the lumen 748 prior todelivering the fluid.

FIG. 24 shows an end 796 of the biasing device 746 contacting the flange760. The compressed biasing device 746 can exert a force in the proximaldirection to prevent uncontrolled movement of the distal sheath 720and/or prosthetic device 770. The fluid pressure in the chamber 743 canbe increased to controllably move the distal sheath 720 in the distaldirection. After an open end 800 of the distal sheath 720 moves distallypast the distal end 774 of the prosthetic device 770, the distal end 774can be allowed to extend outwardly. Referring to FIG. 25, the proximalsheath 731 can be moved from the open position (FIG. 25) back to theclosed position (FIG. 22) using the actuation mechanism 716 (FIG. 18).The biasing device 746 can urge the distal sheath 720 from the openposition (FIG. 25) back to the closed position (FIG. 22).

FIGS. 26-29 are a series of views of a method of deploying theprosthetic device 770 within the heat H using a trans-septal approach.FIG. 26, for example, shows a guidewire 800 positioned in the mitralvalve MV, and FIG. 27 shows the delivery capsule 712 positioned in themitral valve MV. FIG. 28 shows the delivery capsule 712 in a partiallyopen configuration, and FIG. 29 shows the delivery capsule 712 in adeployment configuration and the deployed prosthetic device 770.

Referring first to FIG. 26, the guidewire 800 is positioned to extendthrough the mitral valve MV and into the left ventricle LV. A guidecatheter 810 can be positioned through a puncture or opening 811 in aseptum 813, and the delivery capsule 712 can be delivered out of theguide catheter 810 and advanced along the guidewire 800.

FIG. 27 shows the delivery capsule 712 positioned between the posteriorand anterior leaflets 812, 814. An upstream or atrial rim 815 of theprosthetic device 770 can be positioned relative to the mitral valve MV.The proximal sheath 731 can be moved proximally to unsheathe theupstream or atrial end 772 of the prosthetic device 770 while thedownstream or ventricular end 774 of the prosthetic device 770 isretained by the piston device 722.

Referring next to FIG. 28, the unsheathed atrial end 772 is expandedoutward to contact the mitral valve MV. Until the atrial end 772 engagesthe native tissue, the ventricular end 774 of prosthetic device 770 isretained by piston device 722 within distal sheath 720 to prevent axialmovement of prosthetic device 770 relative to catheter body 714. Afterthe deployed portion of the prosthetic device 770 is seated in themitral valve MV, fluid is delivered through the elongated catheter body714 to hydraulically move the distal sheath 720 from the closed position(FIG. 28) to the open position (FIG. 29). More specifically, FIG. 29shows the prosthetic device 770 in a fully deployed configuration. Thedelivery capsule 712 can then be returned to the closed configuration,pulled through the left atrium, and removed from the heart H.

FIG. 30 is an isometrical view of a distal portion of a catheterconfigured in accordance with yet another embodiment of the presenttechnology. In this embodiment, a distal portion 837 of the catheter caninclude a delivery capsule 842 and an elongated catheter body 844(“catheter body 844”). The delivery capsule 842 can include ahydraulically actuatable sheath 850 and a cover assembly 852. In thisembodiment, sheath 850 is configured to contain substantially the entirelength of prosthetic device 880, while cover assembly 852 serves tocover the open proximal end 871 of sheath 850.

FIGS. 31 and 32 are isometrical cutaway views of the distal portion 837of FIG. 30. Referring to FIGS. 31 and 32 together, the catheter body 844can include an inner shaft 845 and an outer member or shaft 846. Theinner shaft 845, for example, extends through a lumen 849 of the coverassembly 852 and is connected to a piston device 854. The outer member846 can be a tubular member that surrounds a guide portion 847 of thecover assembly 852. A control unit can be coupled to the guide portion847.

The delivery capsule 842 can further include a sheath restrainingmechanism 860 (“restraining mechanism 860”) with a tether 862 configuredto provide a resisting force that opposes a direction of movement of thesheath 850 relative to the piston device 854. In some embodiments, forexample, the tether 862 provides a resistive force to resist distalmovement of the sheath 850 relative to the piston device 854. Theresistive force can be overcome to move the sheath 850 and to compensatefor forces, if any, produced by the prosthetic device. In someembodiments, for example, the tether 862 can minimize, limit, orsubstantially eliminate the effect of forces, if any, produced by theprosthetic device to prevent or limit uncontrolled movement (e.g., axialjumping and self-ejection) of the prosthetic device and/or uncontrolledmovement of the sheath 850.

FIG. 32 shows the tether 862 with a proximal portion 864 at leastpartially wrapped around a hub 869 of a head 866 of the piston device854. A distal portion 870 (FIG. 31) of the tether 862 can be fixedlycoupled to the sheath 850. For example, one or more fasteners (e.g., setscrews, pins, etc.) or other features (e.g., a clamp, welds, etc.) canfixedly couple the distal portion 870 to the sheath 850. In oneembodiment, the tether 862 is locked in place by one or more screws(e.g., flat-bottom set screws). In other embodiments, however, thetether 862 may be secured in place using other suitable techniques. Atorque (e.g., a torque of about 11 oz-in) can be applied to the screws,which in turn frictionally hold the tether 862. The distal portion 870of the tether 862 may then cut to a desired minimum length and housed ina cap 879 (e.g., a hollow cap) of the sheath 850. Additionally oralternatively, the distal portion 870 can wrap about an internalcomponent (e.g., a spool, a pin, etc.) of the sheath 850. The internalcomponent can be removed to adjust the length of the tether 862connecting the piston device 854 to the sheath 850. In some embodiments,the tether 862 can be a wire made of nitinol, spring steel, plastic, orcombinations thereof. In one particular embodiment, the tether 862 is ametal wire (e.g., a wire comprising nitinol, spring steel, etc.) with adiameter of about 0.012 inch (0.35 mm). Other diameters can be selectedbased on the desired forces for deploying the prosthetic device. Theillustrated restraining mechanism 860 has the single tether 862. Inother embodiments, however, any number of tethers can be used.Additionally, the restraining mechanism 860 can include, withoutlimitation, one or more biasing devices, such as springs. The biasingdevice(s) can urge the delivery capsule 842 towards the containmentconfiguration.

FIGS. 33-35 illustrate a method of deploying a prosthetic device 880.More specifically, FIG. 33 shows the delivery capsule 842 in thecontainment configuration, FIG. 34 shows the delivery capsule 842 in apartially open configuration, and FIG. 35 shows the delivery capsule 842in a deployment configuration. Referring to FIG. 33, the open proximalend 871 of the sheath 850 is received in an open distal end 895 of thecover assembly 852. Fluid can flow along a lumen 881 and into a fluidchamber 892. A sufficient volume of fluid can be delivered into thefluid chamber 892 to push the sheath 850. When the hydraulic force(e.g., the force component in the distal direction) overcomes theresistive force provided by the restraining mechanism 860, the sheath850 moves in the distal direction relative to the piston device 854. Insome embodiments, the tether 862 can slip along a screw (e.g., a setscrew) to allow distal movement of the sheath 850. For example, thetether 862 can slide relative to a torque-loaded set screw applyingpressure to the tether 862 to allow distal movement of the sheath 850and unsheathing of the prosthetic device in a controlled fashion. Insome embodiments, the tether 862 can deform (e.g., plastically deform,elastically deform, etc.). In some embodiments, for example, the tether862 experiences primarily elastic deformation. The hydraulic forces inthe fluid chamber 892 can be decreased to allow the tether 862 to returnto its initial state to pull the sheath 850 back to the closed position(FIG. 33). In other embodiments, the tether 862 can experience primarilypermanent deformation. FIG. 34 shows an unsheathed portion 892 of theprosthetic device 880 expanding outwardly through an opening 890. Thevolume of fluid in the fluid chamber 892 can be increased to move thesheath 850 from an intermediate position (FIG. 34) to an open position(FIG. 35).

FIG. 36 is a cross-sectional view of a distal portion of a catheterconfigured in accordance with various embodiments of the presenttechnology. A distal portion 904 can include a delivery capsule 910 andan elongated catheter body 940 (“catheter body 940”). The deliverycapsule 910, for example, includes a sheath 912, a piston device 914,and a positioner in the form of a ratchet element 924. The sheath 912includes a hollow inner rod 944 that extends through the ratchet element924 such that the ratchet element 924 facilitates controlled delivery ofa prosthetic device throughout a substantial portion of the pistonstroke (e.g., throughout most of the piston stroke). A biasing device930 can react against a self-ejection load of a prosthetic device 962(if any) for controlled delivery of the prosthetic device 962 throughoutmost of the entire piston stroke.

The sheath 912 and a cover 916 can define the containment chamber 960.The catheter body 940 can include an outer member 942 coupled to thepiston device 914 and the inner rod 944 coupled to the sheath 912. Amounting portion 952 of the biasing device 930 can be fixedly coupled tothe inner rod 944. The piston device 914 includes a piston head 920 anda sealing member 922. The ratchet element 924 can be fixedly coupled tothe piston head 920 and can include engagement features 926 a, 926 b(collectively “926”).

FIGS. 36 and 37 illustrate a method of deploying the prosthetic device962. For example, the cover 916 can be moved proximally along elongatedcatheter body 940. Fluid can flow along a lumen 972 of the inner rod 944and through a port 980. The fluid can fill a fluid chamber 915 and causedistal movement of the sheath 912. FIG. 37 shows the end 982 of thebiasing device 930 contacting the engagement features 926. The biasingdevice 930, for example, can exert a biasing force that can be overcomeby the hydraulic forces to further move the sheath 912 in the distaldirection. The prosthetic device 962 moves outwardly through a gap 970.The ratchet element 924 can self-seat within the biasing device 930 andensure that the biasing device 930 is properly positioned. In someembodiments, the engagement features can be centered relative to thespring end 982. The ratchet element 924 can inhibit or prevent rotationof the piston head 920.

FIG. 38 is an isometric view of the ratchet element 924 configured inaccordance with an embodiment of the present technology. The ratchetelement 924 can include, for example, a tubular main body 1000 and aplurality of engagement features 926. The engagement features 926 canbe, without limitation, fingers, notched members, cantilevered members,or other features capable of mating with the biasing device 930. In someembodiments, the engagement features 926 can extend inwardly to closelysurround the inner rod 944 (FIG. 37). In some embodiments, theengagement features 926 can be biased against the inner rod 944 suchthat the ends of the engagement features 926 slidably contact the innerrod 944. In other embodiments, the ratchet element 924 may includedifferent features and/or have a different configuration.

FIG. 39 is a partially schematic cross-sectional side view of thedelivery capsule 910 ready for assembly. The ratchet element 924 canfacilitate assembly of the delivery capsule 910. An end 1004 of theinner rod 944 can be inserted into an opening 1006 of the ratchetelement 924. The engagement features 926 can help guide the end 1004into the outer member 942. The piston device 914 can be moved into aninterior region 1020 of the sheath 912 such that the sealing member 922(FIGS. 36 and 37) forms a seal with the inner surface 1028 of the sheath912. The biasing device 930 (FIGS. 32 and 33) can then be coupled to theinner rod 944.

FIG. 40 is an isometric view of a catheter 1108 configured fordelivering a prosthetic device in accordance with various embodiments ofthe present technology. The catheter 1108 can include an elongated body1110 (“catheter body 1110”), a control unit 1123, and a delivery capsule1100. The delivery capsule 1100, for example, includes a hydraulicallyactuatable distal sheath 1125 and a mechanically actuatable proximalsheath 1127. The control unit 1123 can include a drive mechanism 1130for actuating the proximal sheath 1127, a rotational control assembly1131 for rotating the catheter body 1110 relative to control unit 1123,an articulation mechanism 1132, and a side-steering assembly 1134. Thecontrol unit 1123, for example, has features and functionality similarto the control unit 210 of FIG. 3, except as detailed below.

FIG. 41 is a cross-sectional isometric view of the control unit 1123,and FIG. 42 is a side view of the drive mechanism 1130. Referring toFIGS. 40-42 together, the drive mechanism 1130 can include a retractionlocking mechanism 1175 (FIG. 40) and the drive mechanism 1139.Generally, the retraction locking mechanism 1175 (“locking mechanism1175”) can be used to lock and unlock the drive mechanism 1130. When thedrive mechanism 1130 is unlocked, a user can rotate a handle 1140 tomove the proximal sheath 1127.

As best seen in FIG. 41, the drive mechanism 1130 can include the handle1140, a drive member 1142, and a connection assembly 1144. The drivemember 1142 can include a proximal end 1160 connected to the handle1140, a distal end 1143 (FIG. 42) connected to the connection assembly1144, and a threaded main body 1146. The main body 1146 extends throughan internally threaded collar 1151, which is held by an outer housing1152. In some embodiments, the drive member 1142 is a drive screw. Thelength, thread pitch, and other characteristics of the drive member 1142can be selected based on, for example, the desired travel of theproximal sheath 1127.

Referring to FIG. 42, the connection assembly 1144 can include a hubassembly 1162 and a fitting 1164. The hub assembly 1162 can include amain body 1170 and a coupler 1172. The main body 1170 can include athreaded feature, such as a nut (e.g., a threaded lead-screw nut, a lowfriction nut, etc.), or a threaded passageway. In some multi-pieceembodiments, for example, the main body 1170 can include one or morenuts. In one-piece embodiments, the main body 1170 can have aninternally threaded passageway. A receiving feature 1177 (e.g., anopening, a hole, etc.) of the main body 1170 can receive a plunger 1173(FIG. 40) of the locking mechanism 1175.

The coupler 1172 is configured to engage the fitting 1164 such thattranslation of the coupler 1172 causes translation of the fitting 1164along a shaft 1180. In some embodiments, the coupler 1172 extends alongopposite sides of the fitting 1164. In other embodiments, the coupler1172 can be a pin, fastener, or other structure capable of coupling thehub assembly 1162 to the fitting 1164. The fitting 1164 can be acompression fitting that is fixedly coupled to the shaft 1180.

Referring to FIGS. 42 and 43 together, the stop 1184 can be positionedalong the shaft 1180 and can be translationally fixed to the housing1152 (FIG. 43) to limit the distance of travel of the fitting 1164. Thelongitudinal length of the stop 1184 can be increased or decreased todecrease or increase the length of travel of the fitting 1164. Inoperation, a user can manually rotate the handle 1140 (indicated byarrow 1141 of FIG. 40) to displace the hub assembly 1162 in the proximaldirection (indicated by arrow 1218 of FIG. 42). As the hub assembly 1162moves along the drive member 1142, the coupler 1172 moves the fitting1165 in the proximal direction (indicated by arrow 1219 of FIG. 42). Inthis manner, the hub assembly 1162 and fitting 1164 can move togetherwhen the hand 1140 is rotated.

As beset seen in FIG. 42, the fitting 1164 can include engagementfeatures in the form of threads 1176 that engage the coupler 1172. Auser can rotate a handle 1194 (FIGS. 40 and 41) to rotate the shaft 1180and the fitting 1164 to move the fitting 1164 relative to the hubassembly 1162.

FIG. 43 is a detailed side view of a portion of the control unit 1123 ofFIG. 41. The rotational control assembly 1131 can include a mount device1190, a fitting assembly 1192, and the handle 1194. The fitting assembly1192, for example, can include a pair of fittings 1199A, 1199B. Thefittings 1199A, 1199B can be, without limitation, Luer fittings or othertypes of fittings that can establish fluid communication with the shaft1180 and another component, such as a fluid line or other fluid source.

Referring again to FIG. 40, a user can rotate both the steering knob1210 and handle 1212 to steer the delivery capsule 1100 towards a targetsite. The rotational control assembly 1131 can be used to rotationallyposition the delivery capsule 1100 and prosthetic device containedtherein about a longitudinal axis of the elongated catheter body 1110.In some embodiments, a posterior side of the prosthetic device can bealigned with the posterior leaflet using, for example, a marker locatedon the posterior side of the prosthetic device, a marker located onposterior side of the prosthetic device, and/or a marker on one or bothof the sheaths 1127, 1125. Once the delivery capsule 1100 is positionedat the target site, the handle 1140 can be rotated about a rotationalaxis 1214 (FIG. 42) to retract the proximal sheath 1127 in a controllermanner.

Securing tools (e.g., clamps, hemostats, etc.) can be used to positionthe delivery capsule 1100. The catheter body 1110 includes a nut 1204coupled to a distal end 1206 of an outer guide sheath 1123. A securingtool can grip the nut 1204 to manually position the delivery capsule1100. Such embodiments can be manually positioned using open orsemi-open procedures. The nut 1204 can be a hexagonal nut or other typeof nut configured to be gripped by a securing tool.

Prosthetic devices may have a preferential delivery orientation. Forexample, if the treatment site is at the mitral valve, the configurationof the prosthetic device may be selected to match the anatomy of themitral valve. The prosthetic device can be moved to a desiredorientation (e.g., a desired rotational position relative to thedelivery site, a desired axial position relative to the delivery site,etc.). Because a delivery capsule may be generally symmetric (e.g.,rotationally symmetric about its longitudinal axis), it may be difficultto determine the orientation (e.g., rotational position) of theprosthetic device relative to the delivery site. Systems, catheters, andfeatures for orienting prosthetic devices relative to the native anatomyare discussed in connection with FIGS. 44-76. The features for orientingprosthetic devices can be incorporated into the catheters disclosedherein (e.g., catheters discussed in connection with FIGS. 1F and2A-43).

FIG. 44 shows a trans-apical catheter 1250 configured for delivering aprosthetic device within a mitral valve MV. The catheter 1250 caninclude a positioning assembly in the form of a rotational positioningassembly 1260 (“positioning assembly 1260”) and the delivery capsule1262. The positioning assembly 1260 is positioned in an opening 1270 ofthe mitral valve MV. An intravalve positioner 1290 of the positioningassembly 1260 and a marker 1272 on delivery capsule 1262 can be used toposition the delivery capsule 1262 at a desired rotational positionrelative to the mitral valve MV. The intravalve positioner 1290 ispreferably radiolucent, being composed of a radiopaque material orcontaining a marker or dye (e.g., radiopaque dye), or it may haveradiopaque marker couple or affixed to it. Alternatively, it may bevisualized using ultrasound or other suitable technique. When the mitralvalve MV closes, the mitral valve MV can move the intravalve positioner1290 from a misaligned position (shown in dashed line in FIG. 44) to theillustrated aligned orientation in FIG. 45. With the physicianvisualizing the device using, e.g., fluoroscopy, the delivery capsule1262 can be rotated about its longitudinal axis 1263 to move the marker1272 to an aligned position relative to the intravalve positioner 1290(FIG. 45).

FIG. 45 shows the delivery capsule 1262 rotationally aligned with theintravalve positioner 1290. In this arrangement, the marker 1272 andintravalve positioner 1290 can lie in the same plane. The aligneddelivery capsule 1262 can then be advanced distally into the mitralvalve MV.

FIG. 46 is an isometric view of a distal portion 1280 of a catheterconfigured in accordance with various additional embodiments of thepresent technology. The distal portion 1280 can include, for example,the positioning assembly 1260, the delivery capsule 1262, and anelongated catheter body 1282. The positioning assembly 1260 can includethe intravalve positioner 1290 and a rod 1292. The intravalve positioner1290 is configured to rotate about an axis of rotation 1294. The marker1272 can extend generally parallel to a longitudinal axis 1300 of thedelivery capsule 1262. The length of the marker 1272 can be selected toallow convenient determination of the orientation of the marker 1272. Insome embodiments, the length L is generally equal to the length of theprosthetic device contained in the delivery capsule 1262. The marker1272 can be laterally adjacent the prosthetic device and used to axiallyalign the prosthetic device. In the illustrated embodiment, the marker1272 can be located on an exterior surface 1298 of the delivery capsule1262. In other embodiments, however, the marker 1272 can be locatedalong an interior surface of the delivery capsule 1262, embedded in thesidewall of the delivery capsule 1262, or at another desired location.Additionally, the marker 1272 can have a wide range of differentconfigurations (e.g., a series of parallel lines, dots, or other shapes,a zig-zag configuration, a serpentine configuration, etc.) and can be atdifferent orientations suitable for evaluating the orientation of thedelivery capsule 1262. When the prosthetic device is loaded into thedelivery capsule 1262, the orientation of the prosthetic device can beselected based on the position of the marker 1272. For example, afeature (e.g., an anchor, positioning member, or the like) of theprosthetic device can be angularly offset from or angularly aligned withthe marker 1272. For example, anchors for contacting leaflets can beoffset an angle (e.g., an angle in a plane that is generallyperpendicular to the longitudinal axis 1300) about 90 degrees from themarker 1272.

FIG. 47 is a top view of a portion of the positioning assembly 1260, andFIG. 48 is a cross-sectional view of the positioning assembly 1260 ofFIG. 47 taken along line 48-48. Referring to FIGS. 47 and 48 together,the intravalve positioner 1290 can be rotatably coupled to the rod 1292.In other embodiments, the intravalve positioner 1290 is fixedly coupledto the rod 1292, which is rotatably coupled to the delivery capsule1262. The intravalve positioner 1290 can have a generally planar shapeand can have a length L, a width W, and a thickness t (FIG. 48) selectedto allow natural functioning of the mitral valve MV. The length L can beless than a length of an opening of the mitral valve. The width W can beselected such that the flaps of the mitral valve can securely hold theintravalve positioner 1290 while the delivery capsule 1262 is rotated.When the mitral valve is closed (FIG. 50), the native leaflets sealagainst the opposing faces of the intravalve positioner so as to sealand prevent backflow of blood through the mitral valve MV.

The intravalve positioner 1290 can comprise a material that enhancesviewing. For example, the intravalve positioner 1290 can be made, inwhole or in part, of a radiopaque material to provide viewing underfluoroscopy. In some embodiments, the intravalve positioner 1290 caninclude one or more markers (e.g., radiopaque markers, echocardiographicmarkers, etc.). The markers of the intravalve positioner 1290 and themarker 1272 (FIG. 46) can be viewed simultaneously. In some embodiments,the intravalve positioner 1290 is a rudder (e.g., a swiveling rudder)with a non-planar configuration. The non-planar configuration can beselected based on the configuration of the anatomical features in whichthe intravalve positioner is placed. In other embodiments, however, theintravalve positioner 1290 may include other features and/or have adifferent arrangement.

Referring to FIG. 48, the rod 1292 can include one or more rotationfeatures 1306 (e.g., annular bands, bearings, etc.) that permit rotationof the intravalve positioner 1290 relative to the rod 1292. The rod 1292can define a guidewire lumen 1310 and can be made, in whole or in part,of plastic, thermoplastic elastomers (e.g., resins such as Pebax®),metal, or combinations thereof. In non-guidewire embodiments, the rod1292 can have a solid cross-section.

FIGS. 49-53 show one method of positioning the delivery capsule 1262within the mitral valve MV. Generally, the intravalve positioner 1290can be positioned within the mitral valve MV. The mitral valve MV cancause rotation of the intravalve positioner 1290 from a misalignedposition to an aligned position. The delivery capsule 1262 can bealigned with the intravalve positioner 1290. After aligning the deliverycapsule 1262, the delivery capsule 1262 is inserted into the mitralvalve MV, and the prosthetic device can be deployed.

FIG. 49 shows a guidewire 1314 positioned between an anterior leaflet ALand a posterior leaflet PL of the mitral valve MV. A tip 1316 of theguidewire 1314 can be positioned in the left ventricle. In thisembodiment, the intravalve positioner 1290 can be moved over theguidewire 1314 and inserted into an opening 1320 of the open mitralvalve MV. FIG. 49 shows the intravalve positioner 1290 in a misalignedorientation. When the mitral valve MV closes on the intravalvepositioner 1290, the anterior leaflet AL and posterior leaflet PL cancause rotation of the intravalve positioner 1290 such that theintravalve positioner 1290 is aligned with the curved coaptation line1330 defined by a coaptation zone 1328 defined by the anterior leafletAL and posterior leaflet PL. FIG. 50 shows the intravalve positioner1290 generally parallel to the coaptation line 1330. As the mitral valveMV opens and closes, it can continue to reposition the intravalvepositioner 1290 along the coaptation line 1330.

Referring to FIG. 50, the marker 1272 is angularly offset from theintravalve positioner 1290 relative to a longitudinal axis 1300 of thecatheter. The catheter body 1282 can be rotated clockwise about thelongitudinal axis 1300, as indicated by arrow 1342, to align the marker1272 with the positioner 1290. FIG. 51 (and FIG. 45 describedpreviously) show the marker 1272 aligned with the intravalve positioner1290 relative to the longitudinal axis 1300. FIG. 45, for example, showsthe marker 1272 aligned with intravalve positioners 1290 in thesuperior-inferior direction when viewed from the side.

FIG. 52 shows the delivery capsule 1262 ready to be delivered into themitral valve MV. The delivery capsule 1262 can be translated distally,indicated by arrow 1291, without an appreciable amount of rotation tomaintaining alignment of the delivery capsule 1262. The marker 1272 canbe viewed to confirm that alignment has been maintained. FIG. 53 showsthe delivery capsule 1262 ready to deploy a prosthetic device (notshown). The marker 1272, for example, can be generally positioned alongthe coaptation line 1330. The delivery capsule 1262 can includeretaining features (e.g., posts, pins, or the like) that can inhibitrotation of the prosthetic device, thereby maintaining alignment of theprosthetic device. When properly positioned, the delivery capsule 1262can be opened to release the prosthetic device.

FIGS. 54-56 are a series of views of a method of positioning a distalportion 1345 of a catheter in accordance with another embodiment of thepresent technology. Referring to FIG. 54, for example, the distalportion 1345 can include a delivery capsule 1350 and a positioningassembly 1352. The delivery capsule 1350 can include an alignmentfeature in the form of a marker 1356. The positioning assembly 1352 caninclude an intravalve positioner 1360 and a rod assembly 1362. The rodassembly 1362, for example, can include a distal rod member 1370, aproximal rod member 1372, and an alignment feature 1374. In thisembodiment, the distal rod member 1370 is fixedly coupled to theintravalve positioner 1360 and the alignment feature 1374. The proximalrod member 1372 may be rotatably coupled to the distal rod member 1370and fixedly coupled to the delivery capsule 1350. The alignment feature1374 can include, without limitation, one or more bearings, swivels, orother features that allow rotation between the rod members 1370, 1372.

In operation, when the mitral valve MV closes, the anterior leaflet ALand the posterior leaflet PL can move the intravalve positioner 1360 toan aligned position. FIGS. 55 and 56, for example, show the intravalvepositioner 1360 is an aligned position. The delivery capsule 1350 ofFIG. 55 can be rotated (as indicated by arrow 1377) about itslongitudinal axis 1357 to align the marker 1356 with an alignmentfeature 1363. For example, the delivery capsule 1350 of FIG. 55 can berotated about 90 degrees about the longitudinal axis 1357 in a clockwisedirection to align the marker 1356 with the alignment feature 1363. FIG.56 shows the markers 1356, 1363 aligned with one another relative to thelongitudinal axis 1377. The aligned delivery capsule 1350 of FIG. 56 isready to be advanced into the mitral valve MV.

The delivery capsules discussed in connection with FIGS. 44-56 can bealigned with the mitral valve prior to positioning the delivery capsuleswithin the valve. However, delivery capsules of catheters can also bealigned with mitral valves when the delivery capsules are positionedwithin the mitral valves, as discussed below in connection with FIGS.57-66.

FIG. 57, for example, shows a distal portion 1400 of a catheterpositioned in a mitral valve MV. FIG. 58 is a cross-sectional view ofthe distal portion 1400. Generally, distal portion 1400 can interactwith tissue to indicate the position of the distal portion 1400 relativeto one or more native anatomical structures of the heart. In someembodiments, for example, the distal portion 1400 can apply a fluidicforce to tissue to alter the position of the tissue, thereby indicatingthe orientation (e.g., longitudinal position, rotational position, etc.)of the distal portion 1400. For example, the distal portion 1400 canoutput fluid to move the anterior leaflet, posterior leaflet, or otheranatomical structures of the mitral valve MV. Additionally oralternatively, the distal portion 1400 can output fluid to move thedistal portion 1400 relative to one or more anatomical structures of themitral valve MV.

FIGS. 57 and 58 show a position indicator 1403 in the form of ports 1404outputting fluid (represented by arrows) to move the anterior leaflet ALfrom an initial position 1420 to a displaced position 1422 (shown indashed line). The position of the anterior leaflet AL can be viewed, forexample, via echocardiography. The delivery capsule 1402 can be rotatedabout an axis of rotation 1426 to rotationally align the deliver device1402 with the mitral valve MV. The maximum amount of displacement of theanterior leaflet AL caused by the fluid wall typically occur when theports 1404 face the anterior leaflet AL. Once the delivery capsule 1402is located at the desired orientation, the delivery capsule 1402 candelivery a prosthetic device.

FIG. 59 is an isometric view of a catheter system 1430 for delivering aprosthetic device configured in accordance with various embodiments ofthe present technology. The catheter system 1430 can include, forexample, an elongated catheter body 1432 (“catheter body 1432”), acontrol unit 1434, and a fluid system 1442. The fluid system 1442 isconfigured to independently deliver fluids to the lines 1444, 1446.Fluid flowing through the line 1444 can be delivered distally along thecatheter body 1432 and out of the ports 1404. For example, fluid flowingthrough the line 1446 can be delivered distally along the catheter body1432 and used to hydraulically operate the delivery capsule 1402. Thefluid system 1442 can include, without limitation, one or morepressurization devices, containers (e.g., internal tanks or containers),valves, controllers, and/or power sources. The control unit 1434 caninclude an actuator element 1450 movable along a slot 1460 to move acover 1462 of the delivery capsule 1402. In other embodiments, thecontrol element 1450 can be used to move the sheath 1464 distally.

FIG. 60 is a cross-sectional view of the distal portion 1400 of thecatheter system 1430 taken along line 60-60 of FIG. 59. The deliverycapsule 1402 can include, for example, a piston device 1470 (illustratedschematically in dashed line) positioned within a sheath 1464. The ports1404, for example, may comprise a plurality of through-holes 1474 (onlyone port is identified). The through-holes 1474 can be spaced apart fromone another and positioned in a linear arrangement to apply a radiallydirected fluid force to the mitral valve MV. In some embodiments, forexample, the through-holes 1474 are substantially evenly spaced apartfrom one another in a direction that is substantially parallel to alongitudinal axis 1480 of the delivery capsule 1402. In otherembodiments, however, the through-holes 1474 can define a serpentineconfiguration, a substantially zig-zag configuration, or other suitableconfiguration and pattern.

FIGS. 61-64 show a method of positioning the delivery capsule 1402 inaccordance with one embodiment of the present technology. The prostheticdevice 1472 may have a preferential deployment position to engage, forexample, tissue of the heart (e.g., anterior leaflet AL, posteriorleaflet PL, anterior annulus AA, posterior annulus PA, etc.). Forexample, the portion of the prosthetic device 1472 adjacent the ports1404 can be configured to engage the anterior tissue (e.g., anteriorleaflet AL, anterior annulus AA, etc.). Once the delivery capsule 1402is at the desired position, the delivery capsule 1402 can release theprosthetic device 1472.

Referring first to FIG. 61, the delivery capsule 1402 is ready to beinserted into the mitral valve MV. A guidewire 1481 can be insertedbetween the leaflets PL, AL. After positioning the guidewire 1482, thedelivery capsule 1402 can be advanced distally over the guidewire 1482and into the mitral valve MV. The length of the delivery capsule 1402positioned directly between the leaflets PL, AL can be selected basedupon the size of a prosthetic device 1472 (shown schematically in dashedline in FIG. 61), the position of the prosthetic device 1472 relative tothe delivery capsule 1402, and other procedure parameters.

FIG. 62 shows the delivery capsule 1402 positioned in the mitral valveMV. A tip 1484 of the guidewire 1482 is positioned in the left ventricleLV. The ports 1404 are arranged to face a coaptation line 1493 (FIG. 61)between the anterior and posterior leaflets AL, PL. Accordingly, iffluid is delivered out of the ports 1404, the fluid can flow along thecoaptation line 1493 (FIG. 61) and cause minimal displacement of theleaflets PL, AL. Additionally, movement (if any) of the posterior andanterior leaflets PL, AL may not be clearly identifiable under manyvisualization techniques. Thus, it may be difficult to determine whetherthe ports 1404 face the right side or left side of the mitral valve.

FIGS. 63 and 64 shows the ports 1404 facing the anterior leaflet AL.Referring to FIG. 63, for example, the anterior leaflet AL can contactthe delivery capsule 1402. Fluid can be delivered out of the ports 1404to, for example, displace the anterior leaflet AL. FIG. 64 shows fluid(represented by arrows) outputted towards the anterior leaflet AL. Thefluid can be outputted to maintain a gap between the anterior leaflet ALand the delivery capsule 1402. For example, the anterior leaflet AL canmove between a fully open position and a partially open position (shownin dashed line). In some procedures, the fluid can keep the anteriorleaflet AL in a fully open position (e.g. spaced well apart from thedelivery capsule 1402 and adjacent to the heart wall).

Referring to FIG. 65, fluid can flow along a lumen 1490, into acontainment chamber 1435, and through the ports 1404. Otherconfigurations can be used to deliver fluid to the ports 104. The fluidcan be saline or other suitable biocompatible fluid. In someembodiments, the fluid is a viewable fluid (e.g., a radio opaque fluid,a fluid containing a radiopaque material or markers, or the like). Thefluid can be viewed to evaluate the orientation of the delivery capsule1402.

FIG. 66 is a cross-sectional view of a distal portion 1500 of a catheterconfigured in accordance with various embodiments of the technology. Thedistal portion 1500 can include, for example, a delivery capsule 1502configured to output fluid without disrupting a prosthetic device 1510.Fluids F₁, F₂ can be independently delivered through the deliverycapsule 1502 to position the delivery capsule 1402 and actuate thedelivery capsule 1502 at different times. The delivery capsule 1502 caninclude a distal sheath 1520 and a proximal sheath or cover 1522. Thedistal sheath 1520 can include a position indicator 1528 and apassageway 1530. The position indicator 1528 can include a plurality ofspaced apart ports 1534 in fluid communication with the passageway 1530.The passageway 1530 extends proximally through a rod 1540 of the distalsheath 1520. To position the delivery capsule 1502, the fluid F₁ canflow distally along the passageway 1530 towards an end 1544 of thedistal sheath 1520. The fluid F₁ can flow through a U-shaped section1550 of the passageway 1530 and proceed proximally along a feedpassageway 1522. The fluid F₁ is configured to flow along the feedpassageway 1552 and out of the ports 1534.

Fluid F₂ can flow distally along a lumen 1560 and, in some embodiments,can operate a piston device 1562 (shown schematically in dashed line).The fluid F₂ can be delivered to loosen the distal sheath 1520 from theproximal sheath 1522. The fluid F₁ can then be outputted to position thedelivery capsule 1502. After positioning the delivery capsule 1502, theflow of the fluid F₁ can be inhibited or stopped, and the fluid F₂ canbe used to hydraulically actuate the distal sheath 1520. In otherembodiments, the delivery capsule 1502 may include a differentarrangement and/or have different features.

FIGS. 67 and 68 show a distal portion 1600 comprising an elongatedcatheter body 1602 (“catheter body 1602”), a delivery capsule 1604, anda position indicator in the form of a mechanical positioner assembly1610 movable between a delivery state for delivery through a guidecatheter 1660 and a tissue-contacting state for engaging tissue of theheart. The positioner assembly 1610, for example, can include an arrayof positioners in the form of deployable members 1602 a-f (collectively“deployable members 1620”) configured to help position the deliverycapsule 1604 relative to the mitral valve MV. For example, thedeployable members 1620 can be deployed to guide the delivery capsule1604 into the mitral valve MV, to keep the delivery capsule 1604positioned within the mitral valve MV, and/or to otherwise position(e.g., axially align, rotationally align, etc.) the delivery capsule1604 relative to anatomy of the heart. The deployable members 1620 canbe made, in whole or in part, of radiopaque material or may comprise oneor more radiopaque markers. The members 1620 can be viewed underfluoroscopy to help position the delivery capsule 1604 and/or locateanatomical features of the heart. In some embodiments, tips 1621 of themembers 1620 can carry radiopaque markers used to locate the annulus1634, the inner surface 1632 of the atrial wall AW, or otheranatomically features of interest.

FIG. 69 shows the delivery capsule 1604 positioned in the guide catheter1660, and FIG. 70 shows the delivery capsule 1604 after delivery out ofthe guide catheter 1660. Referring first to FIG. 69, the guide catheter1660 can hold the members 1620 in the delivery state (e.g., a collapsedconfiguration, an unexpanded configuration, etc.). The delivery capsule1604 can be moved out of an opening 1666 at an end 1664 of the guidecatheter 1660. As the members 1620 exit the end 1664, the members 1620can moved to the tissue-contacting state (e.g., a deployedconfiguration, an expanded configuration, etc.).

Referring next to FIG. 70, the members 1620 c, 1620 f are shown varyingbetween the delivery state (shown in solid line) and thetissue-contacting state (shown in dashed line). The members 1620, forexample, can be self-deploying or deployable using deploying devices(e.g., one or more balloons, push rods, etc.). The members 1620 can becoupled to the proximal sheath 1654 via one or more joints, pivots,welds, or the like. The dimensions (e.g., lengths, cross-sectionalprofiles, etc.), composition, and/or number of the members 1620 can beselected based on the location of the treatment site and/or the tissueto be contacted. In the illustrated embodiment, six members 1620 in theform of flexible elongated arms or tines can be made, in whole or inpart, of metal, polymers, or other materials suitable to contact tissueof the heart H. In other embodiments, however, the number of members1620 may vary.

The transverse dimension defined by the members 1620 can be selected toavoid passing the members 1620 through the mitral valve MV. In someembodiments, for example, the transverse diameter may be greater than aninner diameter (e.g., a minimum diameter, a maximum diameter, etc.)defined by the inner region of the annulus 1634 (FIG. 68). The members1620 can be configured contact opposing sides of the atrial wall.

One method of deploying the prosthetic device 1657 comprises deliveringthe delivery capsule 1604 through the left atrium LA and into the mitralvalve MV. In particular, the members 1620 of the delivery capsule 1620can be moved to the tissue-contacting state of FIG. 68. The members 1620positioned to contact the tissue of the annulus 1634 may be lesscompliant than the tissue of the leaflets. Thus, when the members 1620contact heart tissue on the atrial side of the annulus 1634, the members1620 can prevent or limit movement of the delivery capsule 1604 in thedistal or downstream direction. A tip 1621 f of the member 1620 f can bedeformed to prevent damage or trauma to the atrial wall AW. In someprocedures, the catheter body 1602 can apply a distally or downstreamdirected force to the delivery capsule 1604 to keep the members 1620seated on the annulus 1645 while the delivery capsule 1604 deploys theprosthetic device 1657. In some embodiments, the members 1620 can alsobe configured to contact the leaflet bases 1640, 1644 of the anteriorand posterior leaflets AL, PL, respectively. The distal sheath 1656 canbe advanced distally into the left ventricle LV while the members 1620substantially prevent distal movement of the proximal sheath 1654. Afterthe prosthetic device 1658 has been deployed, the catheter can be pulledproximally and removed from the subject. The delivery capsule 1604 canalso be used in trans-apical approaches.

FIG. 71 shows a delivery capsule 1680 positioned in a mitral valve MV,and FIG. 72 shows positioners in the form of deployable members 1684 a,1684 b (collectively “members 1684”). Referring to FIGS. 71 and 72together, the delivery capsule 1680 can include a cover 1688 and asheath 1689. The members 1684 can be moved distally through passageways1686 a, 1686 b and out of corresponding openings 1690 a, 1690 b. In someembodiments, the members 1684 can be manually pushed through thepassageways 1686 a, 1686 b. In other embodiments, however, the members1684 can be move using, for example, an advancing device (e.g., amotorized pusher assembly, an actuator, etc.). The members 1684 can haveatraumatic tips 1687 a, 1687 b (FIG. 72) with pre-formed curvedconfigurations, blunted end, or the like. Additionally or alternatively,the tips 1687 a, 1687 b can be made of a highly compliant material thatdeforms to prevent or limit injury or trauma to the tissue of the heart.

As best seen in FIG. 71, the delivery capsule 1680 can be delivered overa guidewire 1692 and into the mitral valve MV. The sheath 1689, forexample, can be positioned between the posterior leaflet PL and theanterior leaflet AL. The openings 1690 a, 1690 b are positionedsuperiorly of the contact interface between the leaflets PL, AL and thesheath 1689. The members 1684 a, 1684 b can be moved until the tips 1687a, 1687 b contact the heart wall and/or tissue of the annulus 1691. Adistal force can be applied to press the members 1684 a, 1694 b againstthe annulus 1691, thereby seating the members 1684. In some embodiments,a slight pressure can be continually applied to hold the deliverycapsule 1680 in a seated position. The prosthetic device 1693 can bedeployed while maintaining its longitudinal position relative to themitral valve MV. The members 1684 a, 1684 b can be held against theannulus 1691 to prevent movement of the prosthetic device 1693 in asuperior-inferior direction while the prosthetic device 1693 isdeployed.

Positioner assemblies of FIGS. 67 and 68 and FIGS. 71 and 72 can also beused in transapical approaches. By way of example, the delivery capsule1604 of FIGS. 67 and 68 can be delivered into the mitral valve MV viathe left ventricle LV, and the members 1620 can be configured to beseated on the ventricular side of the annulus 1634 defining the leftventricle LV. The members 1620 can be positioned on distal or atrial endof delivery capsule 1604. Other positions and configurations of themembers 1620 can also be used.

FIGS. 73 and 74 illustrate a method of positioning a distal portion of acatheter using a transapical approach in accordance with additionalembodiments of the technology. Referring to FIG. 73, for example, adelivery capsule 1700 is ready to be seated in a mitral valve MV andincludes a hydraulically actuatable sheath 1702 and a positionerassembly in the form of deployable members 1704 a, 1704 b (collectively“members 1704”) rotatably coupled to the sheath 1702. The members 1704can be moved from an undeployed state or a delivery state 1710 to adeployed state 1712 (shown in dashed line). In this embodiment, theouter surfaces 1724 of the members 1704 in the undeployed state ordelivery state are configured to be generally flush with the exteriorsurface 1730 of the main body 1718. The sheath 1702 can include a mainbody 1718 and receiving features 1720 a, 1720 b (FIG. 74). The receivingfeatures 1720 may comprise, without limitation, recesses, slots, orother features, capable of at least partially receiving the respectivemembers 1704.

FIG. 73 shows pins 1732 pivotally coupling the members 1704 to a mainbody 1718. Biasing members or push rods can urge the members 1704outwardly. Tethers coupled to the members 1704 can be used to controlmovement of the members 1704 towards the deployed position 1712. In someembodiments, tethers can be used to hold the members 1704 in theundeployed positions 1710. When the tethers are lengthened, biasingdevices move the members 1704 to the deployed positions 1712. In otherembodiments, however, flexible members can couple the members 1704 tothe main body 1711.

A transapical approach can be used with the delivery capsule 1700. Thedelivery capsule 1700 can be into the mitral valve MV via the leftventricle LV. After proximal ends of the members 1704 have cleared themitral valve MV, the members 1704 can be moved to the deployed state1712.

After deploying the members 1704, the delivery capsule 1700 can be movedproximally, as indicated by arrow 1750 of FIG. 73. FIG. 74, for example,shows members 1704 having tissue-contacting tips 1760 a, 1760 b(collectively “tips 1760”) contacting the cardiac tissue. The members1704 can be made, in whole or in part, of radiopaque material or maycomprise one or more radiopaque markers can be viewed under fluoroscopy.In some embodiments, tips 1760 can carry radiopaque markers used tolocate anatomically features of interest. After deploying the prostheticdevice 1716 using a piston device 1756, the members 1704 can be returnedto the undeployed positions 1710. The delivery capsule 1700 can then bemoved from the heart.

The catheters disclosed herein can also include other types ofpositioning features. In some embodiments, for example, a deliverycapsule can have an asymmetrical profile. When the delivery capsule isrotated, the profile of the delivery capsule can be used to determineits orientation. For example, a radiopaque sheath can have asymmetricalshape. Under fluoroscopy, the viewable profile of the sheath can be usedto determine the rotational position of the delivery capsule. Mechanicalposition indicators can include, without limitation, one or more pushrods, deployable arms, or other types of positioner assemblies. In someembodiments, both fluid position indicators and mechanism positionindictors can be used.

Locators can be used to locate anatomical features, position deliverycapsules, or otherwise identify features of interest. FIGS. 75 and 76,for example, show a locator in the form of valve locator 1800 configuredto identify the location of leaflets AL, PL of the mitral valve MV. Thevalve locator 1800 in a viewing configuration can include avisualization feature 1804 that contacts the inferior surfaces 1810,1812 (FIG. 76) of the anterior and posterior leaflets AL, PL,respectively.

The valve locators 1800 can include a shaft 1820 and the visualizationfeature 1804. In some embodiments, the valve locator 1800 is made ofhighly conformable material to prevent damaging tissue while thevisualization feature 1804 is moved to the illustrated position. Theshaft 1820 can be made, in whole or in part, of metal, a polymer, anelastomer and can be flexible to navigate along a delivery path. Thevisualization feature 1804 can include a proximal portion 1830, a distalend or portion 1834, and a main body 1838. The proximal portion 1830 isconnected to the shaft 1820. The main body 1838 can be configured towrap about the anterior and posterior leaflets AL, PL.

The visualization feature 1804 can be made, in whole or in part, of avisualizable material. In embodiments where visualization comprisesfluoroscopy, for example, the visualization feature 1804 can be made, inwhole or in part, of a radiopaque material. Other types of materials canbe used for other types of visualization techniques. The visualizationfeature 1804 can also be made, in whole or in part, of a shape memorymaterial, such as nickel-titanium (e.g., nitinol), shape memory plasticor polymers, copper-nickel-aluminum alloy, or the like so as to assume adesired shape in an unconstrained condition. In some embodiment, theshape memory material can have one or more shape-transitiontemperatures. When the temperature of the shape memory material reachesa shape-transition temperature, the visualization feature 1804 canassume a preset configuration. In some embodiments, the visualizationfeature 1804 can change shapes when the warm blood warms thevisualization feature 1804. Additionally or alternatively, a fluid(e.g., a warm or hot fluid), heaters (e.g., resistive heaters, Peltierdevices, etc.), or other types of active heating elements can be used tochange the temperature of the visualization feature 1804. In non-shapememory embodiments, the visualization feature 1804 can be made, in wholeor in part, of metals (e.g., steel, titanium, aluminum, etc.), polymers(e.g., conductive polymers), or other resilient materials. For example,the delivery sheath 1850 of FIG. 76 can be made of rigid plastic. As thevisualization feature 1804 is delivered out of an end 1852 of thedelivery sheath 1850, the visualization feature 1804 can assume thedelivered configuration.

After positioning the visualization feature 1804 on the inferior side ofthe mitral valve MV, the delivery sheath 1850 can be pulled proximallyto expose the visualization feature 1804 and allow it to assume itsunconstrained shape. Shaft 1820 is then retracted to move thevisualization feature 1804 against the anterior and posterior leafletsAL, PL. The main body 1838 can extend posteriorally from the proximalportion of 1830 and wraps around the intersection of the posteriorleaflet and the anterior leaflet as shown in FIG. 75. Of course, variousother shapes may be used which will seat in a known position relative tothe native anatomy to provide a reference to guide the positioning ofthe prosthetic device.

With a slightly pressure applied to leaflets, a physician can view theposition of the base of the leaflets AL, PL. In some embodiments, thevisualization feature 1804 is configured to engage the junction of theanterior and posterior leaflets and the annulus. The physician can thusidentify the location of the annulus and other anatomical features ofthe mitral valve based, at least in part, on the position of theposition feature 1804.

Valve locator 1800 can be used in combination with the cathetersdisclosed herein. For example, the valve locator 1800 can serve as aguidewire that is delivered into the heart. After positioning the valvelocator 1800, the delivery capsule can be moved over the valve locator1800. Other types of visualization locators can also be used. Intransapical approaches, a visualization locator can be delivered throughthe left ventricle, through an opening the mitral valve, and into theleft atrium. The visualization locator can be deployed to engage theannulus, the junction between the leaflets and the annulus, or otherfeatures of interest.

The embodiments of catheters, catheter components, prosthetic devices,and associated methods disclosed herein can be mixed and matched basedon, for example, the procedure to be performed. It will be appreciated,for example, that specific elements, substructures, advantages, uses,and/or other features of the different embodiments can be suitablyinterchanged, substituted or otherwise configured with one another. Forexample, the mechanical position indicators discussed in connection withFIGS. 44-56 can be incorporated into the catheters and/or deliverycapsules discussed in connection with FIGS. 2-43. By way of anotherexample, the fluid position indicators discussed in connection withFIGS. 57-65 can be incorporated into the delivery capsules discussed inconnection with FIGS. 2A-43. The orientation evaluation process caninvolve, without limitation, determination of (1) relative position(s)between one or more features of a catheter and the target site, (2)relative position(s) between one or more features of a catheter and aprosthetic device, and (3) absolute position(s) of one or more featuresof a catheter and/or prosthetic device.

The target delivery sites can be at different location within a subject.The embodiments disclosed herein can be used to delivery devices totarget delivery sites in the vascular system, respiratory system,digestive system, or other systems of a patient. In the vascular system,the target delivery sites can be within in the heart, arteries, or thelike. Within the heart, any of the native valves may be targeted,including the mitral, aortic, or tricuspid valve. Target delivery sitesin the respiratory system can be within the trachea, lungs, or the like.Target delivery sites in the digestive system can be located along thestomach, colon, intestines, etc. The prosthetic devices can be selectedbased on the location target delivery site. The prosthetic devices canbe, without limitation, self-expanding devices, non-self-expandingdevices (e.g., devices expandable via a balloon), stents (e.g.,self-expanding stents, balloon expanding stents, coronary stents,ureteral stents, prostatic stents, aneurysm stents, peripheral stents,tracheobronchial stents, etc.), grafts (e.g., self-expanding grafts,intraluminal grafts, etc.), occlusion devices (e.g., septal deviceocclusion devices, patent foramen ovale occlusion devices, etc.), valves(e.g., one-way valves, duckbill valves, check valves, valves withleaflets or flaps, etc.), implants (e.g., micro-pumps, implantableelectrodes, etc.), or the like.

FIG. 77 shows a kit 1900 that can include a catheter 1902, a device1904, and packaging 1905. The catheter 1902, for example, can be any ofthe catheters discussed herein. The device 1904 can be a prostheticdevice loadable into a delivery capsule 1910 of the catheter 1902. Insome embodiments, the kit 1900 can include an array of prostheticdevices. A physician can select one of the prosthetic devices based on,for example, the anatomy of the subject. The packaging 1905 can besterilized packaging that includes, for example, a tray, a bag, a pouch,and/or the like.

The kit 1900 can further include a container 1918 and instructions foruse 1921. The container 1918 can hold packing substance (e.g., a gel, aflowable substance, a fluid, etc.). For example, the packing substancecan be a lubricant that reduces or limits friction between the device1904 and the delivery capsule 1910. A syringe 1919 can be used todeliver the packing substance into the delivery capsule 1910. In someprocedures, the packing substance can be delivered onto the device 1904prior to loading the device 1904 into the delivery capsule 1910. Inother procedures, the packing substance is delivered onto surfaces ofthe delivery capsule 1910 before, during, and/or after loading thedevice 1904. In other embodiments, the kit 1900 may have a differentarrangement and/or include different features. The instructions for usemay include instructions for the use of the catheter 1902 and device1904. In preferred embodiments, the instructions will compriseinstructions for implanting the prosthetic device in the heart to repairor replace a native heart valve in accordance with the methods describedelsewhere herein.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of thetechnology, as those skilled in the relevant art will recognize. Forexample, while steps are presented in a given order, alternativeembodiments may perform steps in a different order. The variousembodiments described herein may also be combined to provide furtherembodiments. As provided above, the present application incorporates thesubject matter in (1) International PCT Patent Application No.PCT/US2012/043636, entitled “PROSTHETIC HEART VALVE DEVICES ANDASSOCIATED SYSTEMS AND METHODS,” filed on Jun. 21, 2012; (2) U.S.Provisional Application No. 61/549,037, entitled “SYSTEM FOR MITRALVALVE REPLACEMENT,” filed on Oct. 19, 2011; (3) International PCT PatentApplication No. PCT/US2012/061215, entitled “DEVICES, SYSTEMS ANDMETHODS FOR HEART VALVE REPLACEMENT,” filed on Oct. 19, 2012, and (4)U.S. Provisional Patent Application No. 61/605,699, entitled “SYSTEM FORMITRAL VALVE REPLACEMENT,” filed on Mar. 1, 2012. Each of theseapplications is incorporated herein by reference in its entirety.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

We claim:
 1. A system for delivering a prosthetic heart valve device forimplantation at a native heart valve of a patient, the systemcomprising: an elongated catheter body; and a delivery capsule coupledto the elongated catheter body and configured to be hydraulically drivenbetween a containment configuration for holding the prosthetic heartvalve device and a deployment configuration for deploying the prostheticheart valve device, wherein the delivery capsule comprises— a biasingdevice configured to urge at least a portion of the delivery capsuletowards the containment configuration when the delivery capsule movesfrom the containment configuration towards the deployment configuration;a sheath; a piston device positioned within the sheath, the pistondevice has a head configured to translationally restrain the prostheticheart valve device; and a sealing member positioned between the head andthe sheath to form a fluid-tight seal with the sheath.
 2. The system ofclaim 1 wherein the delivery capsule comprises a containment chamberconfigured to contain the prosthetic heart valve device and a fluidchamber, wherein the fluid chamber is fluidically sealed from thecontainment chamber and in fluid communication with a fluid lumenextending along the elongated catheter body.
 3. The system of claim 2wherein the biasing device includes a spring positioned to be compressedas the delivery capsule moves towards the deployment configuration tounsheathe the prosthetic heart valve device when fluid is deliveredthrough the fluid lumen and into the fluid chamber.
 4. A system fordelivering a prosthetic heart valve device for implantation at a nativeheart valve of a patient, the system comprising: an elongated catheterbody; and a delivery capsule coupled to the elongated catheter body andconfigured to be hydraulically driven between a containmentconfiguration for holding the prosthetic heart valve device and adeployment configuration for deploying the prosthetic heart valvedevice, wherein the delivery capsule comprises— a biasing deviceconfigured to urge at east a portion of the delivery capsule towards thecontainment configuration when the delivery capsule moves from thecontainment configuration towards the deployment configuration; and ahousing configured to hold the prosthetic heart valve device, thehousing including: a first portion having a closed distal first end andan open proximal first end; and a second portion having an open distalsecond end and a closed proximal second end, wherein the first andsecond portions are movable away from one another and at least one ofthe open proximal first end and the open distal second end is configuredto release the prosthetic heart valve device therethrough.
 5. The systemof claim 4 wherein the delivery capsule further comprises a pistondevice positioned within the housing, a containment chamber, and a fluidchamber, wherein the fluid chamber is fluidically sealed from thecontainment chamber and in fluid communication with a fluid lumenextending along the elongated catheter body such that at least one ofthe first portion and the second portion is driven axially to unsheatheat least a portion of the prosthetic heart valve device positioned inthe containment chamber when fluid is delivered through the fluid lumenand into the fluid chamber.
 6. The system of claim 4 wherein the biasingdevice is configured to urge the first and second portions towards oneanother.
 7. The system of claim 4 wherein the delivery capsule includesa piston device positioned within the housing, the piston device and thehousing define a fluid chamber in fluid communication with a fluid lumenin the elongated catheter body, the delivery capsule being movabletowards the deployment configuration by delivering fluid through thefluid lumen and into the fluid chamber to overcome a biasing forceprovided by the biasing device.
 8. A system for delivering a prostheticheart valve device for implantation at a native heart valve of apatient, the system comprising: an elongated catheter body; and adelivery capsule coupled to the elongated catheter body and configuredto be hydraulically driven between a containment configuration forholding the prosthetic heart valve device and a deployment configurationfor deploying the prosthetic heart valve device, wherein the deliverycapsule comprises— a biasing device configured to urge at least aportion of the delivery capsule towards the containment configurationwhen the delivery capsule moves from the containment configurationtowards the deployment configuration; a distal sheath; a proximalsheath; a distal piston device movably positioned in the distal sheathsuch that the distal sheath moves distally relative to the distal pistondevice when fluid is delivered into a distal fluid chamber defined bythe distal sheath and the distal piston device; and a proximal pistondevice movably positioned in the proximal sheath such that the proximalsheath moves proximally relative to the proximal piston device whenfluid is delivered into a proximal fluid chamber defined by the proximalsheath and the proximal piston device.
 9. The system of claim 8, furthercomprising a prosthetic heart valve device positioned within at leastone of the proximal and distal sheaths and between the distal pistondevice and the proximal piston device, wherein the distal sheath and theproximal sheath are movable away from one another to unsheathe at leasta portion of the prosthetic heart valve device.
 10. The system of claim8, further comprising a prosthetic heart valve device positioned withinand translationally restrained by the delivery capsule, wherein thedelivery capsule is configured to release the prosthetic heart valvedevice after a deployed portion of the prosthetic heart valve device isseated in a native valve of the heart.
 11. The system of claim 1 whereinthe biasing device includes a spring that is compressed as the deliverycapsule moves away from the containment configuration to unsheathe anentire axial length of the prosthetic heart valve device.
 12. The systemof claim 11 wherein the sheath is movable proximally to compress thespring between a stop coupled to the sheath and a shoulder of theelongated catheter body.
 13. The system of claim 1 wherein the elongatedcatheter body includes a fluid lumen in fluid communication with thedelivery capsule, the delivery capsule is configured to move from thecontainment configuration to the deployment configuration by deliveringfluid along the fluid lumen and into the delivery capsule to overcome abiasing force provided by the biasing device.
 14. The system of claim 1wherein the biasing device includes a spring having a proximal end and adistal end, the distal end of the spring moves proximally along theelongated catheter body towards the proximal end of the spring when thedelivery capsule moves from the containment configuration towards thedeployment configuration.
 15. A system for delivering a prosthetic heartvalve device for implantation at a native heart valve of a patient, thesystem comprising: an elongated catheter body; and a delivery capsulecoupled to the elongated catheter body and configured to behydraulically driven between a containment configuration for holding theprosthetic heart valve device and a deployment configuration fordeploying the prosthetic heart valve device, wherein the deliverycapsule comprises— a distal sheath; a proximal sheath; and a biasingdevice configured to urge at least a portion of the delivery capsuletowards the containment configuration when the delivery capsule movesfrom the containment configuration towards the deployment configuration,wherein the basing device includes a spring having a proximal end and adistal end, the distal end of the spring moves proximally along theelongated catheter body towards the proximal end of the spring when thedelivery capsule moves from the containment configuration towards thedeployment configuration, and wherein the elongated catheter bodyincludes an outer member and an inner member positioned within the outermember, the outer member is coupled to the proximal sheath, the innermember is coupled to the distal sheath, and the outer member is axiallymovable relative to the inner member to move the proximal sheathproximally.